The Regulatory Affairs team at The Polmarc Group provides regulatory support for the development of biologics, drugs and devices. Our consultants have a clear understanding of the requirements for completion of each element of regulatory submissions to FDA and Health Canada.

Regulatory support includes:

  • Writing/preparing IND, NDA, BLA and CTD submissions
  • Coordinating and preparing for agency meetings
  • Acting as an authorized representative
  • Writing preclinical protocols and phase I through III protocols
  • Labeling and packaging
  • MCA filings
  • Regulatory documentation