- 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
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