FDA Meeting Support

Catalyst Regulatory Affairs staff have extensive experience in preparing and executing regulatory authority meetings: pre-IND, End of Phase 2, pre-NDA, Advisory Committee

  • Full service: meeting planning and execution
    • Initial meeting planning
    • Preparation and submission of meeting request
    • Preparation and submission of briefing document
    • Rehearsals and team preparation
    • Conduct of meeting and follow up
  • Ad hoc consulting on specific components
    • Briefing document review
    • Assessment of questions for FDA
    • Participation in “mock” meetings

Example Process

Type B Meeting Timeline