- Regulatory strategy
- Regulatory interactions
- All regulatory submissions to FDA and EMEA (INDs, CTAs, NDA/BLAs, 510(k), etc.)
- Recall advice and assistance
- FDA meeting preparation, including advisory committee preparation and MOCK AC boards
Epstein Associates will arrange a mock FDA panel meeting.
Our services include the development of a comprehensive panel strategy for the sponsor including organizing a slide presentation, streamlining Q & A and creating a Post Panel Action Report.