Regulatory Affairs

We're excited to help you gain approval for your healthcare product with regulatory agencies like CDSCO in India, USFDA in the US, and EMEA in the EU. We'll guide you through the process of submitting all the necessary documents and information for review, notification, or in response to a request for more information.

Regulatory submissions by Pristyn Research

We're excited to help you gain approval for your healthcare product with regulatory agencies like CDSCO in India, USFDA in the US, and EMEA in the EU. We'll guide you through the process of submitting all the necessary documents and information for review, notification, or in response to a request for more information. With our expertise, we're confident that your product will receive the green light and be on its way to positively impacting countless lives.

Pristyn Research is an expert in regulatory compliance and provides top-notch software solutions to ensure the timely submission of compliant electronic documents. Our experienced submission publishing service specialists and innovative solutions can assist you with any clinical document submission and publishing needs. We are committed to helping you overcome any challenges that may arise during the regulatory submission process.

Pristyn Research specializes in submitting applications like INDs, CTAs, IMPDs, and EOP2s. We have a 100% acceptance rate with the FDA and are familiar with the evolving practices and strategies of the FDA and EMEA. Our medical writers create high-quality protocols, reports, and regulatory documents for the product development process.

Review of Technical Dossiers
Preparation and Submission of Regulatory Dossiers for Clinical Trial Approvals and Marketing Authorizations
Liaising with Regulators for Submission and Approvals
Presentation of Protocols to Regulatory Expert Committees (NDAC, SEC and MDAC in Case of DCGI Submission)
Import Licenses for Investigational Products, Ancillary Supplies and Equipment
Export Licenses for Biological Samples and Residual Investigational Products
Registration of Clinical Trials in National Registries (CTRI)
Safety Reporting: SAE, Annual Reports and Safety Reports
Master Service Agreement Services
SUGAM Portal registration
Regulatory Notifications

Review of Technical Dossiers

Pristyn Research CRO is a distinguished clinical research organization known for its expertise in reviewing technical dossiers before submission to regulatory authorities (CDSCO) in India. With a wealth of experience, we excel in conducting thorough assessments of trial documentation to ensure compliance with regulatory standards and guidelines. Our dedicated team meticulously reviews each component of the dossier, offering valuable insights and recommendations to enhance its quality and completeness. Partner with Pristyn Research CRO for Technical Dossier Review services that bolster the integrity and regulatory compliance of clinical trial submissions, contributing to advancements in medical science and pharmaceutical innovation.

The review of technical dossiers before submitting them to regulatory authorities in India is a critical step in the approval process for new drugs or medical devices. This process ensures that all necessary documentation and data meet the regulatory requirements set forth by agencies like the Central Drugs Standard Control Organization (CDSCO).

Here are the key components and steps involved in the review:

Key Components of the Review of Technical Dossiers:

1.Administrative Information:

This section includes details about the applicant, such as the company name, address, contact information, and responsible personnel. It also provides an overview of the submission, including the type of application and product information.

2.Covering Letter:

The covering letter serves as an introduction to the technical dossier and provides a brief summary of the submission. It also addresses the regulatory authority and outlines the purpose of the application.

3.Product Information:

This section provides comprehensive details about the product, including its name, dosage form, strength, route of administration, and indications for use. It also includes information about the packaging, labeling, and shelf-life of the product.

4.Chemistry, Manufacturing, and Control (CMC) Information:

This component is crucial for drugs and pharmaceuticals. It includes detailed information about the composition, manufacturing process, quality control testing, stability studies, and specifications of the product. This section ensures that the product is of consistent quality.

5.Non-Clinical Data:

Non-clinical data encompasses preclinical studies conducted in laboratories or animals. It includes information on pharmacology, toxicology, and any other relevant studies. These data provide evidence of the product's safety and efficacy prior to human trials.

6.Clinical Data:

This section includes the results of clinical trials conducted on humans. It provides detailed information about study design, patient demographics, endpoints, statistical analyses, adverse events, and conclusions drawn from the clinical trials. Clinical data are essential for evaluating the product's effectiveness and safety profile.

7.Bioequivalence/Bioavailability Studies (if applicable):

For generic drugs, bioequivalence or bioavailability studies are critical. These studies demonstrate that the generic product is equivalent to the innovator product in terms of pharmacokinetics and pharmacodynamics.

8,Pharmacovigilance Data (if applicable):

This section includes information on adverse events and safety monitoring during clinical trials. It also outlines the pharmacovigilance plan for post-marketing surveillance of the product's safety.

9.Regulatory Status in Other Countries (if applicable):

If the product has already received regulatory approval in other countries, this section provides documentation of those approvals. It helps establish the product's safety and effectiveness on a global scale.

10.Risk Management Plan (if applicable):

This plan outlines how potential risks associated with the product will be identified, assessed, and managed throughout its lifecycle. It includes strategies for minimizing and mitigating risks.

Steps in the Review Process:

1.Document Collection and Organization:

The regulatory affairs team gathers all necessary documents and organizes them according to the specific requirements of the regulatory authority.

2.Thorough Evaluation of Each Component:

Experts in various fields, including biostatistics, pharmacology, toxicology, and clinical research, review each component of the technical dossier to ensure compliance with regulatory standards.

3.Gap Analysis and Corrections:

Any deficiencies or gaps in the documentation are identified, and the regulatory team works with relevant departments to address and correct these issues.

4.Data Integrity and Quality Assurance:

Data integrity and quality checks are conducted to ensure that all information provided is accurate, reliable, and consistent.

5.Alignment with Regulatory Guidelines:

The technical dossier is thoroughly compared with existing regulatory guidelines and requirements to ensure full compliance.

6.Preparation of a Summary Report:

A summary report is generated, highlighting key findings and any outstanding issues that need to be addressed before submission.

7.Final Review and Approval:

The final review is conducted by senior regulatory experts to ensure that all aspects of the technical dossier meet the regulatory standards. Once approved, the submission is finalized.

8.Submission to Regulatory Authority:

The finalized technical dossier is submitted to the appropriate regulatory authority along with the required application forms and fees.

9.Response to Regulatory Queries (if necessary):

In case the regulatory authority has any queries or requests for additional information, the company responds promptly with the necessary details.

10.Follow-Up and Communication:

The regulatory affairs team maintains open communication with the regulatory authority and provides any additional information or documentation as requested.

Conclusion:

The review of technical dossiers before submission to regulatory authorities in India is a meticulous and crucial process. It ensures that all required information and data are accurately documented and compliant with regulatory standards, ultimately contributing to the approval and marketing of safe and effective medical products in the Indian market.

Preparation and Submission of Regulatory Dossiers for Clinical Trial Approvals and Marketing Authorizations

Pristyn Research CRO is a distinguished clinical research organization renowned for its expertise in the meticulous preparation and submission of Regulatory Dossiers for Clinical Trial Approvals and Marketing Authorizations to regulatory authorities in India. With a deep understanding of local regulatory frameworks, we navigate the complex approval process with precision and compliance. Our experienced team ensures that all required documentation is compiled, reviewed, and submitted in accordance with regulatory standards, expediting the approval process for clinical trials and marketing authorizations. Partner with Pristyn Research CRO for Regulatory Dossier Preparation services that streamline the path to conducting trials and launching pharmaceutical products in the Indian market.

The preparation and submission of regulatory dossiers is a critical step in the process of obtaining approvals for clinical trials and marketing authorizations for new medical products in India. These dossiers contain comprehensive information about the product, its safety and efficacy data, manufacturing processes, and more.

Here's a detailed explanation of how this process takes place and its importance in India:

1.Preparation of Regulatory Dossiers:

Gathering Data: The process begins with the collection of extensive data related to the product. This includes information about the active ingredients, manufacturing processes, preclinical and clinical trial results, safety profiles, and more.
Dossier Compilation: Regulatory affairs professionals, in collaboration with cross-functional teams, compile the collected data into a structured and organized document known as the regulatory dossier.
Formatting and Alignment: The dossier is formatted in accordance with the specific requirements and guidelines provided by the regulatory authority in India, such as the Central Drugs Standard Control Organization (CDSCO).
Risk Assessment and Management Plans: If applicable, risk assessments and risk management plans are included in the dossier to identify and mitigate potential risks associated with the product.

2.Submission Process:

Regulatory Strategy Development: Before submission, a regulatory strategy is developed, outlining the approach for seeking approval and the anticipated timeline for the process.
Pre-submission Meeting (if applicable): Some regulatory authorities offer the option of a pre-submission meeting where the company can seek guidance on the submission process and address any initial concerns.
Application Forms and Fees: The regulatory affairs team completes the necessary application forms and pays the requisite fees for the submission. This includes fees for clinical trial applications and marketing authorization applications.
Comprehensive Review: Prior to submission, the regulatory dossier undergoes a thorough internal review to ensure that all necessary information is included and that the data is accurate and consistent.

3.Importance of Regulatory Dossiers in India:

Compliance with Regulatory Standards: Regulatory dossiers ensure that all aspects of the product, including its development, manufacturing, and clinical testing, adhere to the stringent regulatory standards set by agencies like the CDSCO.
Evidence of Safety and Efficacy: The dossier provides comprehensive evidence of the product's safety and efficacy based on preclinical and clinical data. This is crucial for establishing the product's benefit-risk profile.
Data Transparency and Integrity: A well-prepared regulatory dossier demonstrates transparency and integrity in presenting data. This is essential for building trust with regulatory authorities.
Legal Requirement: Submission of regulatory dossiers is a legal requirement for obtaining approvals to conduct clinical trials and market pharmaceutical products in India.
Patient Safety: Thorough evaluation of the product through regulatory dossiers ensures that only safe and effective products are introduced to the market, safeguarding patient well-being.

4.Carrying Out the Submission:

Documentation Review: The regulatory affairs team conducts a final review of the entire dossier to confirm that it meets the regulatory standards and addresses all requirements.
Submission Tracking: A tracking system is established to monitor the progress of the submission and to ensure that all necessary documentation reaches the regulatory authority.
Response to Regulatory Queries: If the regulatory authority has any queries or requests for additional information, the regulatory affairs team responds promptly with the necessary details.
Follow-Up and Communication: The regulatory affairs team maintains open communication with the regulatory authority and provides any additional information or documentation as requested.
Approval Process: Upon successful submission, the regulatory authority evaluates the dossier and, if satisfied with the data, grants the necessary approvals for clinical trials or marketing authorizations

Conclusion:

The preparation and submission of regulatory dossiers play a crucial role in ensuring that new medical products meet the rigorous standards set by regulatory authorities in India. These dossiers serve as comprehensive documentation of the product's development, safety, and efficacy, ultimately contributing to the approval and marketing of safe and effective medical products in the Indian market.

Liaising with Regulators for Submission and Approvals

Pristyn Research is an expert in meticulous submission and approvals for liaising with regulators in India. Liaising with regulators is a crucial aspect of the clinical research process in India. It involves establishing effective communication and collaboration between the sponsors, regulatory affairs teams, and regulatory authorities such as the Central Drugs Standard Control Organization (CDSCO) for the submission and approval of clinical trials.

Here is a detailed explanation of how this process takes place and how it is carried out:

1.Pre-submission Planning and Strategy:

Regulatory Affairs Expertise: Experienced regulatory affairs professionals play a key role in liaising with regulators. They have an in-depth understanding of the regulatory landscape and guidelines in India.
Regulatory Strategy Development: Before initiating any submission, a comprehensive regulatory strategy is developed. This includes determining the type of application, understanding regulatory requirements, and planning the submission timeline.

2.Establishing Contact and Pre-submission Meetings:

Initial Contact: The regulatory affairs team initiates contact with the regulatory authority to introduce the clinical trial or new product. This may be done through official correspondence or by scheduling a pre-submission meeting.
Pre-submission Meeting (if applicable): In some cases, regulatory authorities offer the option of a pre-submission meeting. This provides an opportunity for sponsors to seek guidance, address initial concerns, and clarify any questions about the submission process.

3.Application Preparation and Submission:

Document Compilation: Regulatory affairs professionals work closely with cross-functional teams to gather, compile, and organize all necessary documents for the application. This includes the clinical protocol, investigator brochure, informed consent forms, and other essential documentation.
Compliance with Regulatory Guidelines: The regulatory affairs team ensures that the application is aligned with the specific requirements and guidelines provided by the regulatory authority in India, such as the CDSCO.
Application Forms and Fees: The team completes the required application forms and ensures that all necessary fees are paid for the submission. This includes fees for clinical trial applications and other regulatory submissions.

4.Review and Response to Regulatory Queries:

Comprehensive Review: Before submission, the regulatory affairs team conducts a thorough internal review of the entire application to ensure that all necessary information is included and that the data is accurate and consistent.
Response to Queries: If the regulatory authority has any queries or requests for additional information, the regulatory affairs team responds promptly with the necessary details. This may involve providing clarifications, additional data, or addressing specific concerns.

5.Follow-Up and Communication:

Ongoing Communication: Throughout the submission and evaluation process, the regulatory affairs team maintains open and transparent communication with the regulatory authority. This includes responding to any additional queries or providing updates on the progress of the application.

6.Post-Submission Activities:

Regulatory Authority Meetings (if applicable): In certain cases, sponsors may have follow-up meetings with the regulatory authority to discuss specific aspects of the application or address any outstanding concerns.
Tracking and Monitoring: The regulatory affairs team establishes a tracking system to monitor the progress of the submission and ensure that all necessary documentation reaches the regulatory authority.

7.Approval Process:

Evaluation by Regulatory Authority: The regulatory authority thoroughly evaluates the application, including the study protocol, safety data, and other relevant information.
Granting of Approvals: If the regulatory authority is satisfied with the data and compliance with regulatory standards, they grant the necessary approvals for the clinical trial or marketing authorization.

Conclusion:

Liaising with regulators for submission and approvals in clinical research is a collaborative effort that requires expertise in regulatory affairs and effective communication with the regulatory authorities. It involves careful planning, thorough preparation of applications, and ongoing dialogue with the regulatory authority to ensure that all necessary approvals are obtained for conducting clinical trials or marketing new medical products in India. This process is vital for ensuring that clinical research is conducted in compliance with regulatory standards, ultimately contributing to the safety and efficacy of new medical interventions.

Pre-Submission Meetings

Pristyn Research is a one stop option to the sponsors to streamline the Pre-submission meetings with regulators. Pre-submission meetings with regulatory authorities are an important aspect of the clinical research process. These meetings provide an opportunity for sponsors and researchers to engage with regulatory authorities before formally submitting applications for clinical trials or marketing authorizations. In India, this interaction typically involves the Central Drugs Standard Control Organization (CDSCO).

Here's a detailed explanation of what pre-submission meetings entail and how they are conducted:

1.Purpose of Pre-Submission Meetings:

Clarification and Guidance: The primary purpose of a pre-submission meeting is to seek clarification and guidance from the regulatory authority regarding the requirements and expectations for the upcoming submission. It allows sponsors to address any concerns or questions they may have about the application process.
Early Feedback: Pre-submission meetings provide an opportunity for regulatory authorities to offer early feedback on the proposed clinical trial protocol or marketing authorization application. This can be invaluable in ensuring that the submission meets regulatory standards.
Risk Mitigation: The meeting can also serve as a platform to discuss potential risks associated with the clinical trial or product, and to strategize on how these risks can be addressed and mitigated.

2.Initiating a Pre-Submission Meeting:

Request and Documentation: Sponsors or their representatives initiate the request for a pre-submission meeting with the regulatory authority. This request is typically accompanied by a comprehensive document outlining the details of the proposed clinical trial or marketing application.
Formal Request: The request is submitted through official channels, and it may include information such as the proposed study protocol, target patient population, primary endpoints, and any specific questions or concerns that the sponsor wishes to address.

3.Preparation for the Meeting:

Study Protocol and Documentation: Sponsors prepare a detailed study protocol and compile all relevant documentation that will be discussed during the meeting. This includes the clinical trial design, informed consent forms, data collection methods, and more.
List of Questions/Concerns: Sponsors may prepare a list of specific questions or concerns they would like to discuss with the regulatory authority during the meeting. This helps ensure that all relevant topics are addressed.
Regulatory Affairs Expertise: Regulatory affairs professionals play a crucial role in preparing for pre-submission meetings. They have in-depth knowledge of regulatory requirements and are instrumental in formulating the meeting agenda.

4.Conducting the Pre-Submission Meeting:

Meeting Arrangements: The meeting is scheduled by the regulatory authority at a mutually convenient time. It may be conducted in person, via teleconference, or through video conferencing, depending on the preferences and availability of the parties involved.
Attendees: Key stakeholders, including representatives from the sponsoring company, regulatory affairs professionals, clinical researchers, and sometimes experts in relevant therapeutic areas, attend the meeting.
Agenda: The meeting follows a structured agenda, which typically includes an overview of the proposed study or application, specific questions from the sponsor, and feedback and recommendations from the regulatory authority.
Discussion and Clarifications: The meeting provides an open forum for discussion, allowing sponsors to seek clarifications, address concerns, and receive feedback from the regulatory authority.

5.Post-Meeting Actions:

Meeting Minutes and Feedback: Following the meeting, the regulatory authority provides minutes or a summary of the discussions, along with any feedback or recommendations. This documentation is crucial for ensuring that the submission aligns with regulatory expectations.
Action Plan: Based on the feedback received, sponsors develop an action plan to address any concerns or make necessary adjustments to the clinical trial protocol or application.

6.Incorporating Feedback into the Submission:

Revised Protocol and Application: Sponsors use the feedback from the pre-submission meeting to revise and refine the clinical trial protocol or marketing authorization application to ensure that it aligns with regulatory expectations.

Conclusion:

Pre-submission meetings with regulatory authorities are a valuable step in the clinical research process. They facilitate open communication, provide early feedback, and help sponsors ensure that their submissions meet regulatory standards. In India, these meetings are conducted with the CDSCO and play a crucial role in ensuring that clinical trials and new medical products are conducted in compliance with regulatory requirements.

Presentation of Protocols to Regulatory Expert Committees (NDAC, SEC and MDAC in Case of DCGI Submission)

Pristyn Research is a distinguished clinical research organization specializing in preparing and presenting Protocols to Regulatory Expert Committees. With a deep understanding of the regulatory landscape, we assist sponsors in crafting comprehensive presentations for committees such as NDAC, SEC, and MDAC, particularly in cases of DCGI submission. Our experienced team ensures that protocols are meticulously presented, addressing all critical aspects for committee review and approval. Partner with Pristyn Research for expert guidance in navigating the regulatory review process, contributing to the successful advancement of clinical trials and the approval of new medical interventions.

In India, the process of presenting protocols to regulatory expert committees is a critical step in gaining approval for clinical trials. These committees, such as the New Drug Advisory Committee (NDAC), Subject Expert Committee (SEC), and Medical Device Advisory Committee (MDAC), play a pivotal role in evaluating the scientific and ethical aspects of proposed studies.

Here's a detailed explanation of how this process is carried out:

1.Preparation of the Protocol:

Before presenting the protocol to regulatory expert committees, sponsors and researchers must develop a comprehensive document outlining the details of the proposed clinical trial. This includes the study design, patient population, primary and secondary endpoints, statistical analysis plan, informed consent forms, and other relevant information.

2.Submission of the Protocol:

The protocol is formally submitted to the regulatory authority, such as the Central Drugs Standard Control Organization (CDSCO) in India. This submission is a prerequisite for seeking approval to conduct the clinical trial.

3.Review by Regulatory Authority:

The regulatory authority conducts an initial review of the submitted protocol to ensure that it meets the basic requirements and is aligned with regulatory guidelines.

4.Assignment to Expert Committees:

Depending on the nature of the study, the protocol may be assigned to one or more expert committees for evaluation. For example, if the submission pertains to a new drug, it may be reviewed by the NDAC. Similarly, for medical devices, the MDAC would be involved.

5.Expert Committee Meetings:

The expert committees, namely NDAC, SEC, and MDAC, hold regular meetings to review and evaluate the protocols. These meetings may occur on a predetermined schedule or as needed based on the volume of submissions.

6.Presentation Format:

The presentation of protocols to expert committees follows a structured format. The presenting team typically includes representatives from the sponsoring company, clinical investigators, and regulatory affairs professionals.

7.Content of the Presentation:

The presentation covers various aspects of the protocol, including:

Study Rationale: The rationale for conducting the study is presented, emphasizing the scientific and clinical significance of the research.
Study Design: Details about the study design, including the type of study (e.g., randomized controlled trial), blinding procedures, treatment arms, and patient population, are discussed.
Endpoints: The primary and secondary endpoints, which serve as key measures of the study's success, are explained.
Informed Consent Process: The informed consent process, including how patients will be informed about the study and their rights, is outlined.
Safety Measures: Safety measures and protocols for monitoring adverse events and ensuring patient safety are detailed.
Statistical Analysis Plan: The plan for analyzing the study data, including methods for data collection, statistical tests, and data interpretation, is presented.
Ethical Considerations: Ethical considerations, including patient confidentiality and protection of human subjects, are addressed.

8.Question and Answer Session:

Following the presentation, the expert committee members have an opportunity to ask questions and seek clarification on various aspects of the protocol.

9.Committee Deliberations and Recommendations:

After the presentation, the expert committee members deliberate and assess the scientific and ethical aspects of the protocol. They may offer recommendations for revisions or modifications.

10.Post-Presentation Actions:

Based on the feedback received during the presentation, sponsors and researchers may need to revise and refine the protocol to address any concerns raised by the expert committees.

11.Final Review and Approval:

Once the revisions are made, the protocol is resubmitted to the regulatory authority for final review. If the expert committees are satisfied with the revisions, they provide their recommendations for approval.

Conclusion:

The presentation of protocols to regulatory expert committees in India is a rigorous and collaborative process that ensures that proposed clinical trials meet scientific and ethical standards. Through structured presentations and open dialogue, the expert committees play a crucial role in evaluating and approving protocols, ultimately contributing to the advancement of clinical research in the country.

Import Licenses for Investigational Products, Ancillary Supplies and Equipment

Pristyn Research CRO is a distinguished clinical research organization with specialized expertise in facilitating Import Licenses for Investigational Products, Ancillary Supplies, and Equipment in strict accordance with regulatory requirements in India. With a deep understanding of local import regulations, we guide sponsors through the intricate process of obtaining the necessary licenses for clinical trials. Our experienced team ensures that all required documentation is prepared and submitted with precision, expediting the importation of essential materials for the conduct of trials. Partner with Pristyn Research CRO for expert assistance in navigating the regulatory landscape, ensuring seamless importation processes for your clinical research endeavours in India.

In clinical research, obtaining import licenses for investigational products, ancillary supplies, and equipment is a crucial step in ensuring that all necessary items required for a study are legally and compliantly brought into the country. This process is regulated by authorities such as the Central Drugs Standard Control Organization (CDSCO) in India. Here is a detailed explanation of what import licenses are and how they are obtained:

1.Definition and Purpose:

Investigational Products: These are the drugs, medical devices, or biologics that are being tested in a clinical trial. They may be either the experimental treatment or a comparator product.
Ancillary Supplies and Equipment: These encompass any additional supplies or equipment necessary for the conduct of the clinical trial, such as medical devices, lab equipment, diagnostic tools, or any other materials required for patient care or data collection.
Purpose: The import licenses for these items ensure that they meet regulatory standards and are used in compliance with ethical and legal guidelines.

2.Regulatory Authority:

In India, the Central Drugs Standard Control Organization (CDSCO) is responsible for overseeing the import of investigational products, ancillary supplies, and equipment for clinical trials.

3.Application Process:

Regulatory Affairs Expertise: Regulatory affairs professionals with expertise in Indian regulatory requirements are instrumental in guiding the application process.
Documentation: Sponsors, along with their regulatory affairs teams, compile a comprehensive set of documents that includes details about the investigational products, ancillary supplies, equipment, and their intended use in the clinical trial.
Application Forms: The appropriate application forms, prescribed by the CDSCO, are completed with all relevant details.

4.Types of Import Licenses:

Form 45: This license is for the import of investigational products for clinical trials.
Form 46: This license is for the import of small quantities of investigational products intended for personal use in emergency situations.
Form 47: This license is for the import of investigational products for test, analysis, or examination in a laboratory.
Form 10: This license is for the import of medical devices.

5.Submission and Review:

The completed application, along with all supporting documents, is submitted to the CDSCO for review. This may be done electronically through the Sugam portal or through physical submission, depending on the CDSCO's current procedures.

The CDSCO evaluates the application to ensure that all necessary information is provided and that the proposed import complies with regulatory standards.

6.Review and Approval Process:

Once the application is received, the CDSCO conducts a review to assess the compliance of the proposed import with regulatory guidelines. This includes ensuring that the investigational products meet quality and safety standards.

If the application meets all requirements, the CDSCO grants the import license. This license specifies details such as the quantity of products allowed for import, their intended use, and the duration of the license.

7.Post-Approval Actions:

After obtaining the import license, sponsors and their regulatory affairs teams coordinate with logistics and supply chain management to ensure that the investigational products, ancillary supplies, and equipment are imported in accordance with the terms specified in the license.

8.Monitoring and Reporting:

Throughout the clinical trial, sponsors must maintain accurate records of all imported items and report any deviations from the approved import plan to the regulatory authorities.

9.Renewal and Amendments:

If there are any changes to the import plan or if additional quantities or items need to be imported, sponsors may need to apply for license amendments or renewals as necessary.

Conclusion:

Obtaining import licenses for investigational products, ancillary supplies, and equipment is a critical aspect of conducting clinical trials in India. It ensures that all items imported for the study meet regulatory standards and are used in compliance with ethical and legal guidelines. Through careful preparation, submission, and review, sponsors and their regulatory affairs teams work in collaboration with the CDSCO to facilitate the importation of essential materials for clinical research. This process ultimately contributes to the successful conduct of clinical trials and the advancement of medical knowledge and treatments.

Export Licenses for Biological Samples and Residual Investigational Products

Pristyn Research CRO is a distinguished clinical research organization known for its proficiency in securing Export Licenses for Biological Samples and Residual Investigational Products in strict compliance with Indian regulatory requirements. With a wealth of experience, we excel in navigating the complexities of the export process, ensuring the safe and compliant transfer of vital materials for further analysis and research. Our dedicated team ensures that all necessary documentation is prepared and submitted in accordance with regulatory standards, expediting the export process while upholding data integrity and patient confidentiality. Partner with Pristyn Research CRO for Export License services that facilitate seamless global collaboration in advancing medical science and pharmaceutical development.

Export licenses for biological samples and residual investigational products are crucial for conducting global clinical trials. These licenses ensure that materials are shipped in compliance with regulatory and ethical standards. In India, the process is regulated by authorities like the Central Drugs Standard Control Organization (CDSCO).

Here is a detailed explanation of what export licenses are and how they are obtained:

1.Definition and Purpose:

Biological Samples: These are specimens collected from human subjects during a clinical trial, including blood, tissue samples, urine, and other bodily fluids.
Residual Investigational Products: These are any unused or leftover investigational products (drugs, medical devices, biologics) after the completion of a clinical trial.
Purpose: Export licenses ensure that biological samples and residual investigational products are transported safely, ethically, and in accordance with regulatory guidelines.

2.Regulatory Authority:

The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority in India overseeing the export of biological samples and investigational products.

3.Application Process:

Regulatory Affairs Expertise: Regulatory affairs professionals with expertise in Indian regulatory requirements guide the application process.
Documentation: Sponsors, along with their regulatory affairs teams, compile a comprehensive set of documents detailing the nature of the materials, their intended use, and ethical considerations.
Application Forms: The appropriate application forms, prescribed by the CDSCO, are completed with all relevant details.

4.Types of Export Licenses:

Form 10A: This license is for the export of biological samples and investigational products.
Form 10B: This license is for the export of small quantities of investigational products intended for personal use in emergency situations.
Form 11:This license is for the export of investigational products for test, analysis, or examination in a laboratory.

5.Submission and Review:

The CDSCO evaluates the application to ensure that all necessary information is provided and that the proposed export complies with regulatory standards.

6.Review and Approval Process:

Once the application is received, the CDSCO conducts a review to assess the compliance of the proposed export with regulatory guidelines. This includes ensuring that the biological samples and investigational products meet quality and safety standards.

If the application meets all requirements, the CDSCO grants the export license. This license specifies details such as the quantity of products allowed for export, their intended use, and the duration of the license.

7.Post-Approval Actions:

After obtaining the export license, sponsors and their regulatory affairs teams coordinate with logistics and supply chain management to ensure that the materials are exported in accordance with the terms specified in the license.

8.Monitoring and Reporting:

Throughout the export process, sponsors must maintain accurate records of all exported items and report any deviations from the approved export plan to the regulatory authorities.

9.Renewal and Amendments:

If there are any changes to the export plan or if additional quantities or items need to be exported, sponsors may need to apply for license amendments or renewals as necessary.

Conclusion:

Obtaining export licenses for biological samples and residual investigational products is a critical aspect of conducting global clinical trials. It ensures that these materials are shipped in compliance with regulatory, ethical, and safety standards. Through careful preparation, submission, and review, sponsors and their regulatory affairs teams work in collaboration with the CDSCO to facilitate the export of essential materials for clinical research. This process ultimately contributes to the successful conduct of clinical trials and the advancement of medical knowledge and treatments.

Registration of Clinical Trials in National Registries (CTRI)

Pristyn Research CRO is a distinguished clinical research organization known for its expertise in the registration of clinical trials in National Registries, particularly the Clinical Trials Registry-India (CTRI). With a deep understanding of regulatory mandates, we ensure that trials are meticulously registered, adhering to all necessary documentation and disclosure requirements. Our experienced team guarantees that trial information is transparently and accurately reported, advancing transparency and trust within the clinical research community. Partner with Pristyn Research CRO for Clinical Trial Registration services that uphold the highest standards of ethics and regulatory compliance, contributing to the progress of medical science and pharmaceutical innovation in India.

Clinical trial registration is a crucial step in promoting transparency, accountability, and ethical conduct in clinical research. In India, the Clinical Trials Registry-India (CTRI) is the designated national registry for registering clinical trials.

Here's a detailed explanation of how the registration process is carried out:

1.Purpose and Importance:

Clinical trial registration aims to provide public access to information about ongoing and completed clinical trials. This transparency helps prevent duplication of research efforts, allows patients to identify and participate in relevant trials, and ensures that research findings are accessible to the wider scientific community.

2.Regulatory Requirement:

Registration of clinical trials is a regulatory requirement in India. The Drugs and Cosmetics (Second Amendment) Rules, 2013, make it mandatory for all clinical trials conducted in the country to be registered with the CTRI before enrolment of the first participant.

3.Registration Process:

Preparation of Trial Information: The first step in the registration process involves gathering comprehensive information about the clinical trial. This includes details about the study protocol, study design, primary and secondary endpoints, inclusion and exclusion criteria, ethical considerations, and more.
CTRI Website Access: Sponsors, principal investigators, or designated individuals responsible for registration must access the CTRI website, which provides a user-friendly platform for submitting trial information.
Creation of an Account: If not already registered, users need to create an account on the CTRI website, providing their contact details and affiliation with the study.

4.Data Entry and Submission:

Logging In: After creating an account, users can log in to the CTRI portal.
Initiating the Registration Process: Users can initiate the registration process by selecting the option to "Submit a New Trial."
Data Entry Forms: The CTRI portal provides structured data entry forms where users can input all relevant information about the clinical trial. This includes details about the study, intervention, objectives, methodology, ethical considerations, and more.
Uploading Documents: In addition to the data entry forms, users are required to upload essential documents such as the study protocol, informed consent form, and ethical approval letter.
Review and Validation: Once all necessary information is provided, the CTRI system performs an initial review to ensure that the data is complete and meets the required standards.

5.Submission Review and Confirmation:

CTRI Review Process: The CTRI team conducts a thorough review of the submitted information to verify its completeness, accuracy, and compliance with regulatory guidelines.
Feedback and Corrections: If any discrepancies or missing information is identified, the CTRI team communicates with the registrant to request necessary corrections or additions.
Final Confirmation: Once all requirements are met, the trial is officially registered, and a unique registration number is provided.

6.Access to Registered Trials:

Public Accessibility: The registered clinical trials, along with their detailed information, are made publicly accessible through the CTRI website.
Search and Browse Functionality: Interested parties, including patients, healthcare professionals, researchers, and regulatory authorities, can search, browse, and access information about registered trials.

7.Post-Registration Updates:

Amendments and Modifications: If there are any changes to the trial protocol or other details after initial registration, users are required to update the information on the CTRI portal.

8.Ethical Considerations:

Ethics Committee Approval: Before a trial can be registered, it must receive approval from an accredited ethics committee. The registration process includes providing details about this approval.

9.Trial Reporting and Results:

Ongoing Reporting: As the trial progresses, registrants are encouraged to provide updates on the trial's progress, including recruitment status and any changes to the protocol.
Reporting of Results: Upon completion of the trial, registrants are expected to report the results, including both positive and negative findings.

Conclusion:

The registration of clinical trials in the Clinical Trials Registry-India (CTRI) is a vital step in ensuring transparency and accountability in clinical research conducted in India. It provides a platform for sharing critical information about ongoing and completed trials, enabling broader access to research findings and facilitating informed decision-making for patients and healthcare professionals. Compliance with the registration process is a regulatory requirement, and it is an integral part of conducting ethical and responsible clinical research in India.

Safety Reporting: SAE, Annual Reports and Safety Reports

Pristyn Research CRO is a distinguished clinical research organization renowned for its expertise in Safety Reporting, including Serious Adverse Events (SAE), Annual Reports, and Safety Reports, in strict compliance with regulatory requirements in India. With a deep understanding of pharmacovigilance and safety monitoring, we ensure that all safety-related information is accurately collected, documented, and reported. Our experienced team is adept at managing safety data throughout the lifecycle of a clinical trial, contributing to the ongoing assessment of a product's safety profile. Partner with Pristyn Research CRO for Safety Reporting services that prioritize participant safety and regulatory compliance, advancing medical science and pharmaceutical development.

Safety reporting in clinical trials is a critical aspect of ensuring the well-being of participants and the integrity of the study. In India, this process is regulated by the Central Drugs Standard Control Organization (CDSCO) and follows international guidelines.

Here's a detailed explanation of how safety reporting, including Serious Adverse Events (SAEs), Annual Reports, and Safety Reports, is carried out in India:

1.Serious Adverse Events (SAEs):

Definition: Serious Adverse Events (SAEs) are untoward medical occurrences or effects that result in death, are life-threatening, require inpatient hospitalization or prolongation of existing hospitalization, result in persistent or significant disability/incapacity, or are considered a congenital anomaly/birth defect.
Reporting Responsibility: It is the responsibility of the principal investigator (PI), sponsor, and other relevant stakeholders to promptly report SAEs to the regulatory authority and the Ethics Committee.
Timelines: SAEs must be reported within a specified timeline, as outlined in the regulatory guidelines. Typically, this is within 24 to 72 hours of becoming aware of the event.
Documentation: All details of the SAE, including the patient's medical history, description of the event, assessment of causality, and follow-up information, must be documented and submitted.
Follow-Up Reporting: In some cases, additional follow-up information may be required, including the outcome of the event and any ongoing medical management.

2.Annual Reports:

Purpose: Annual Reports provide an overview of the progress and safety data of the clinical trial over a specified period.
Content: They include details about the number of participants enrolled, the ongoing status of the trial, any amendments made to the protocol, a summary of SAEs, and an overall assessment of the study's progress.
Submission Timeline: Annual Reports are typically submitted within 60 days of the anniversary of the trial's initiation.

3.Safety Reports:

Definition: Safety Reports encompass periodic updates on the safety data of the trial, including information on SAEs, adverse events (AEs), and other safety-related information.

Types of Safety Reports:

Development Safety Update Reports (DSURs): These reports provide cumulative safety information about the investigational product at specified intervals during the development process.
Periodic Safety Update Reports (PSURs): PSURs are required for post-marketing surveillance and are submitted at specified intervals after a product is granted marketing authorization.
Expedited Safety Reports: In addition to routine periodic reports, expedited reports must be submitted for certain types of SAEs, which are considered unexpected, serious, and suspected to be related to the investigational product.
Submission Timelines: The submission timelines for safety reports are specified in the regulatory guidelines and depend on the type of report. For example, DSURs are typically submitted annually, while expedited reports must be submitted within a specified number of days after becoming aware of the event.

4.Safety Reporting Process in India:

Regulatory Oversight: The CDSCO oversees the safety reporting process in India. It provides specific guidance on the content, format, and submission timelines for SAEs, Annual Reports, and Safety Reports.
Regulatory Affairs Expertise: Regulatory affairs professionals play a crucial role in ensuring that safety reports are prepared and submitted in compliance with regulatory requirements.
Ethics Committee Involvement: The Ethics Committee, which reviews and monitors the clinical trial, also plays a role in overseeing safety reporting. They review SAEs and provide feedback on the management and reporting of safety events.
Communication with Investigators: The principal investigator (PI) is responsible for promptly reporting SAEs to the Ethics Committee and ensuring that all required documentation is submitted in a timely manner.
Follow-Up and Record Keeping: In addition to reporting, it is important to follow up on SAEs and maintain accurate and detailed records of all safety-related information.

Conclusion:

Safety reporting in clinical trials, including the reporting of SAEs, Annual Reports, and Safety Reports, is a critical process that helps ensure the safety and well-being of trial participants. In India, this process is regulated by the CDSCO, and compliance with regulatory guidelines is essential. Through careful documentation, timely reporting, and close collaboration between stakeholders, the safety reporting process contributes to the ethical conduct of clinical research and the protection of participant welfare.

Master Service Agreement Services

Pristyn Research CRO is a distinguished clinical research organization known for its expertise in providing Master Service Agreement (MSA) services in strict adherence to regulatory and legal requirements in India. With a deep understanding of contractual frameworks and industry-specific regulations, we excel in crafting comprehensive MSAs that protect the interests of all parties involved in clinical trials. Our experienced team ensures that MSAs are meticulously drafted, reviewed, and negotiated to ensure compliance with the highest standards of legal and regulatory integrity. Partner with Pristyn Research CRO for MSA services that form the foundation of successful and legally sound collaborations in the field of clinical research.

A Master Service Agreement (MSA) is a legally binding contract that establishes the terms and conditions between two or more parties engaged in a business relationship. In clinical research, an MSA is a crucial document that outlines the framework for collaboration between a sponsor (typically a pharmaceutical or biotechnology company) and a contract research organization (CRO) or other service providers.

Here's a detailed explanation of what an MSA is and how it is carried out in the context of clinical research:

1.Purpose and Importance:

Defining the Relationship: The primary purpose of an MSA in clinical research is to define the scope of work, responsibilities, and obligations of each party involved in the research project.
Risk Management: The MSA helps manage potential risks by clearly outlining issues related to confidentiality, intellectual property, liability, indemnification, and other critical aspects.
Efficiency and Consistency: By establishing a standardized agreement, sponsors and service providers can streamline the contracting process, leading to more efficient collaborations.

2.Key Components of an MSA:

Parties Involved: The MSA identifies the parties involved in the agreement, including the sponsor and the service provider(s).
Scope of Work: It outlines the specific services or tasks that the service provider will perform on behalf of the sponsor. This may include tasks related to clinical trial management, data management, monitoring, etc.
Term and Termination: The MSA specifies the duration of the agreement and the conditions under which it can be terminated, including notice periods.
Payment Terms: It details the financial arrangements, including payment schedules, invoicing procedures, and any milestones or deliverables tied to payments.
Confidentiality and Data Protection: The MSA includes provisions for protecting sensitive information and data generated during the course of the research.
Intellectual Property: It addresses ownership rights and licensing of any intellectual property (such as patents, copyrights, or proprietary information) that may result from the research.
Liability and Indemnification: The MSA outlines the responsibilities and liabilities of each party, including any indemnification clauses in case of legal claims.

3.Negotiation and Drafting:

Legal Expertise: Legal experts, including attorneys specializing in healthcare and contract law, are typically involved in drafting and negotiating the MSA. They ensure that the terms are clear, fair, and legally enforceable.
Review and Approval: Both parties thoroughly review the MSA to ensure that it accurately reflects the agreed-upon terms. Any necessary revisions are discussed and incorporated.

4.Execution and Signature:

Finalization: Once both parties are satisfied with the terms, the MSA is finalized, and the official version is prepared for signature.
Signatories: Authorized representatives from the sponsor and the service provider(s) sign the MSA, indicating their acceptance of the terms and conditions.

5.Implementation and Oversight:

Compliance and Adherence: Throughout the course of the research project, both parties must adhere to the terms outlined in the MSA.
Dispute Resolution: If any issues or disputes arise during the project, the MSA provides a framework for resolving them through negotiation, mediation, or arbitration.

6.Amendments and Addendums:

Flexibility: If circumstances change during the course of the project, amendments or addendums can be made to the MSA to reflect new terms or requirements.

Conclusion:

A Master Service Agreement (MSA) is a critical document in clinical research that establishes the legal framework for collaboration between sponsors and service providers. By clearly defining the scope of work, responsibilities, and obligations of each party, an MSA helps manage risks, protect intellectual property, and ensure a smooth and efficient research process. Legal experts play a crucial role in drafting and negotiating the MSA to ensure that it aligns with the interests of all parties involved. Once executed, the MSA serves as a guiding document throughout the research project, providing a basis for effective collaboration and dispute resolution if needed.

SUGAM Portal Registration

Pristyn Research CRO is a distinguished clinical research organization renowned for its expertise in SUGAM Portal Registration in strict compliance with regulatory requirements in India. With a deep understanding of the local regulatory framework, we facilitate the seamless registration process on the SUGAM portal, ensuring accurate and timely submission of essential clinical trial information. Our experienced team navigates the intricacies of the portal, streamlining the regulatory approval process for clinical trials. Partner with Pristyn Research CRO for SUGAM Portal Registration services that expedite the initiation of trials, contributing to the progress of medical science and pharmaceutical development in India.

The SUGAM portal is an online platform developed by the Central Drugs Standard Control Organization (CDSCO) in India. It serves as an integrated system for the submission, review, and processing of applications related to clinical trials, import and export of investigational products, and other regulatory processes in the field of pharmaceuticals and clinical research.

Here's a detailed explanation of how SUGAM portal registration is carried out:

1.Purpose and Significance:

The SUGAM portal plays a pivotal role in streamlining regulatory processes related to clinical trials and investigational products. It provides a centralized platform for stakeholders, including sponsors, investigators, and regulatory authorities, to submit, review, and track various applications and documents.

2.Preparatory Steps for SUGAM Portal Registration:

Obtaining Necessary Information: Before initiating the registration process, individuals or organizations interested in using the SUGAM portal should gather all required information and documents. This may include identification details, contact information, and relevant affiliations.
Legal and Regulatory Expertise: Given the regulatory nature of the portal, individuals responsible for registration should have a good understanding of Indian regulatory requirements related to clinical research.

3.Accessing the SUGAM Portal:

Website URL: The SUGAM portal is accessible through a designated website provided by the CDSCO.
Creating an Account: To begin the registration process, users need to create an account on the portal. This involves providing personal details, contact information, and organizational affiliations, if applicable.

4.Registration Process:

User Type Selection: The portal offers different user types, such as sponsors, investigators, ethics committees, and regulatory authorities. Users select the relevant category based on their role in the clinical research process.
Verification and Approval: Once the initial registration information is submitted, the CDSCO reviews and verifies the details. Approval for account activation is granted upon successful verification.
Login Credentials: After approval, users receive login credentials, including a username and password, which are used to access the portal.

5.Accessing and Navigating the Portal:

User Dashboard: Upon logging in, users are directed to their respective dashboards, which provide access to various functionalities and applications available on the portal.
Menu Navigation: The portal typically has a menu bar with options to submit new applications, track existing applications, access guidelines and resources, and manage account settings.

6.Submitting Applications and Documents:

Application Types: The SUGAM portal supports various types of applications, including those related to clinical trials, import and export of investigational products, ethics committee registration, and more.
Document Upload: Users can upload the required documents for their specific application. These documents may include study protocols, informed consent forms, investigator brochures, and other regulatory documents.
Data Entry Forms: For certain applications, the portal may include structured data entry forms where users provide information in a standardized format.

7.Review and Processing:

CDSCO Review: Once an application is submitted, the CDSCO reviews the documents and information provided to ensure compliance with regulatory requirements.
Communication and Feedback: The CDSCO may communicate with the applicant for any necessary clarifications or additional information.

8.Application Status Tracking:

Dashboard Updates: Users can track the progress of their applications through the portal's dashboard. It provides real-time updates on the status of each application.
Notification Alerts: The portal may also send notifications or alerts to inform users of any changes in the status of their applications.

9.Post-Approval Actions:

Compliance and Documentation: Once an application is approved, users are responsible for ensuring compliance with the conditions and requirements specified by the CDSCO.
Record Keeping: Users should maintain accurate records of all applications submitted through the portal for future reference.

Conclusion:

The SUGAM portal registration process in India is a critical step for individuals and organizations involved in clinical research and regulatory activities. By providing a centralized platform for application submission and tracking, the portal enhances efficiency and transparency in the regulatory process. Users, equipped with the necessary information and expertise, can navigate the portal to submit applications, track their progress, and ensure compliance with Indian regulatory requirements.

Regulatory Notifications

Pristyn Research CRO is a distinguished clinical research organization known for its expertise in Regulatory Notifications in strict compliance with regulatory requirements in India. With a wealth of experience, we excel in timely and accurate notifications to regulatory authorities, ensuring transparency and adherence to all necessary reporting obligations. Our dedicated team ensures that notifications are prepared and submitted with precision and compliance, contributing to regulatory compliance and patient safety. Partner with Pristyn Research CRO for Regulatory Notifications services that uphold the highest standards of regulatory compliance, advancing medical science and pharmaceutical development in India.

Regulatory Notifications in India:

Regulatory notifications in India pertain to official communications issued by regulatory authorities, primarily the Central Drugs Standard Control Organization (CDSCO), to provide information, updates, or instructions related to the pharmaceutical and healthcare sector. These notifications play a crucial role in maintaining compliance with evolving regulatory requirements. Here's a detailed explanation of what regulatory notifications is and how they are carried out:

1.Purpose and Significance:

Information Dissemination: Regulatory notifications serve as a formal means for the CDSCO to communicate important information to stakeholders, including the pharmaceutical industry, healthcare professionals, clinical researchers, and the general public.
Compliance and Adherence: These notifications provide clear directives on changes in regulations, policies, or procedures, ensuring that all concerned parties remain informed and can adjust their practices accordingly.

2.Types of Regulatory Notifications:

Amendments to Regulations: Notifications may include updates or amendments to existing laws, rules, or guidelines related to drugs, medical devices, clinical trials, and other healthcare-related activities.
Policy Changes: Notifications may announce new policies or changes in existing policies that impact the pharmaceutical and healthcare sector.
Safety Alerts: Regulatory authorities issue notifications to communicate important safety information about drugs, medical devices, or treatments, including recalls or warnings.
Guidance Documents: Notifications may introduce new guidance documents or provide clarifications on existing ones to assist stakeholders in understanding and complying with regulatory requirements.

3.Carrying Out Regulatory Notifications:

Issuing Authority: Regulatory notifications are issued by the CDSCO or other relevant regulatory authorities in India.
Publication Platforms: Notifications are typically published on official government websites, such as the CDSCO website, and may also be disseminated through official gazettes, newsletters, or circulars.
Communication to Stakeholders: The CDSCO ensures that notifications reach their intended audience through various channels, including email notifications to registered stakeholders, publication on the official website, and sometimes through industry associations.

4.Review and Interpretation:

Understanding the Notification: Stakeholders, including pharmaceutical companies, clinical researchers, and healthcare professionals, review each notification to understand the specific changes or information provided.
Legal and Regulatory Expertise: Regulatory affairs professionals and legal experts play a vital role in interpreting notifications to ensure accurate compliance with the updated requirements.

5.Implementation and Compliance:

Timeline for Compliance: Notifications often specify deadlines or effective dates for compliance with the new regulations or policies.
Adapting Practices: Stakeholders must adjust their practices, processes, and procedures to align with the changes outlined in the notification.

6.Impact on Clinical Research:

Clinical Trial Regulations: Notifications may introduce changes in regulations governing the conduct of clinical trials, including requirements for approvals, documentation, and reporting.
Drug Approvals and Licensing: Notifications may outline new procedures or criteria for the approval and licensing of drugs, including generic drugs and new drug entities.

7.Communication and Feedback:

Feedback Mechanism: Stakeholders may have the opportunity to provide feedback or seek clarifications on the notifications through official channels established by the regulatory authority.
Consultation Meetings: In some cases, the regulatory authority may conduct consultations or meetings with stakeholders to gather input on the proposed changes before issuing formal notifications.

8.Record Keeping and Documentation:

Maintaining Records: Stakeholders are responsible for maintaining accurate records of all regulatory notifications and ensuring that compliance efforts are well-documented.

9.Continuous Monitoring:

Stakeholder Responsibility: It is the responsibility of stakeholders to stay informed about new notifications and to regularly monitor official channels for updates.
Professional Associations and Forums: Industry associations and professional forums often play a role in disseminating regulatory information and facilitating discussions among stakeholders.

Conclusion:

Regulatory notifications in India serve as vital tools for keeping stakeholders in the pharmaceutical and healthcare sector informed about changes in regulations, policies, and safety information. Compliance with these notifications is crucial for maintaining adherence to regulatory standards and ensuring the safety and efficacy of pharmaceutical products and clinical research practices. Regulatory affairs professionals, legal experts, and industry associations play essential roles in interpreting and implementing these notifications, ultimately contributing to the integrity and quality of the healthcare system in India.

Regulatory Affairs