Regulatory Support

  • Regulatory agency interface for assigned projects
  • Provide responses to CMC comments from regulatory agencies worldwide
  • Maintain Type V Drug Master File with FDA for BDP facilities
  • Develop submission strategies that expedite agency review.

FDA Pre-IND Meeting Support

  • Initiation and management of FDA Pre-IND meetings
  • Preparation of Pre-IND meeting requests
  • Preparation of CMC documentation required for Pre-IND meetings

FDA IND and International Regulatory Support

  • Provide Chemistry, Manufacturing, and Controls (CMC) Section of IND and IND Amendments, for assigned clinical products
  • Provide responses to FDA Pre-IND and IND CMC comments
  • Provide responses to international regulatory inquiries for assigned projects
Regulatory Affairs
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Regulatory Affairs