Regulatory

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Regulatory Filing Support

The Regulatory Affairs department at GRAM is fully integrated into all our manufacturing activities. We have the ability to assist clients with Clinical Trial Applications (IND/CTA), New Drug Submissions (NDA/BLA/ANDA), and Supplements (PAS, Type I/II). We can provide documentation in Common Technical Document (CTD) format to assist in expediting regulatory filings:

  • Facilitate Regulatory Strategy
  • Facilitate Interaction with Regulatory Authorities
  • Drug Master File
  • Guidance on Regulatory Submissions
  • Prepare Regulatory Documents
  • FDA, EMEA, PDMA, ANVISA, Health Canada