Services

Regulatory Affairs

We at MCR, understand the importance of compliance of drug marketing and its compliance with ever changing regulations of clinical trials. Our in-house regulatory team has thorough knowledge and experience of catering to regulatory needs of the drug, irrespective of phase of its lifer cycle. This includes licensing support, generation of clinical trial regulatory documents, marketing authorization submissions.

Our services include:

  • Regulatory Document Writing/Submission Writing
  • NDA/MAA/NDS/PMA
  • IND/IMPD/IDE
  • Submission Ready: Dossier preparation for Submission to Health Authority.
  • Report Publishing: Ready to submit to Health Authority