• 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.