Regulatory Affairs

Developing an innovative healthcare product (a drug or a biologic, or a medical device) from the proof-of-concept stage to the marketing stage is an expensive and complex process. It involves many years of research and development work.

To save time and money in bringing products to market, product development activities should be conducted in accordance with the related regulatory requirements. Following these require¬ments can streamline development activities and help client to manufacture a product that meets the regulatory standards of client’s targeted jurisdiction(s)—that is, a quality product that is safe and effective for its intended use.

Although information on the regulatory requirements (e.g., laws, guidance documents, international standards) for healthcare product development is readily available, navigating the regulatory system is not simple, and it gets even more complex when dealing with multiple jurisdictions.
To help entrepreneurs who are developing healthcare products, Clinical Development Service Agency (CDSA), has been established as a nodal agency to catalyze development of human clinical trial capacity in India at par with international standards.

CDSA provides regulatory advisory services for development and registration of new drugs, medical devices, cosmetics, diagnostics, Phyto-pharmaceuticals and biopharmaceuticals/biosimilars including Vaccines to SMEs and public funded pre-clinical and clinical stage research projects.

  1. Advice on regulatory processes encompassing product development & registration
  2. Advice / Consultation on regulatory dossier preparationof dossiers, for registration of New Drugs, Medical Devices and Ethics Committee.
  3. Regulatory input to ongoing clinical trials in CDSA,
  4. Regulatory input in planning and compliance certification of GLP- bio analytical lab & Phase 1 facility.
  5. Advice on Registration of Ethics Committees with CDSCO, as per new notification.
  6. Advice and review proposals coming from BIRAC (especially clinical trial protocols)
  7. Technical input (Regulatory program design, faculty identification & preparation of resource materials).
  8. Faculty / Resource person in GCP, Ethics Committee, and Current Regulation of clinical trials of new drugs Training workshops.
  9. Regulatory aspects Query reply from Stakeholders at CDSA website.