Regulatory Affairs

The Regulatory department supports Investigators and SMEs review pre-clinical and clinical trial protocols and other documents as per existing regulatory norms, support in Ethics Committee registration and in reporting of clinical research trials at CTRI. CDSA has the experience and proficiency to guide and advise on the regulatory pathway in all areas like new drugs, medical devices and diagnostics, vaccines, phytopharmaceuticals, biopharmaceuticals and biosimilars, novel cell lines, etc.

The regulatory department services include:

  • Consultation on regulatory dossier preparation
  • Regulatory input to ongoing clinical trials
  • Advice on registration/re-registrations of Ethics Committees (ECs) with CDSCO.


Projects where CDSA has provided regulatory advice and support are enumerated in Projects Section .