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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