Case Study:

Startup Company Outsources Regulatory Affairs and Seeks Process Improvement


Our Client:

A virtual startup company engaged Safis to carry out their regulatory affairs function and to develop a solution to change manufacturing processes to remove ASMs.


Safis deliverables for regulatory affairs:


  • Defined CMC regulatory strategy
  • Defined control strategy
  • Prepared pre-IND briefing document
  • Organized and attended the FDA meeting
  • Prepared module 3 for IND


Safis deliverables for ASM removal:


  • Consult on regulatory aspect of ASMs
  • Interface with FDA regarding protocol review
  • Review and consult on protocol edits
  • Protocol ready for submission via eCTD