Agency Meeting Fundamentals
Veristat regulatory experts have first-hand experience with regulatory agency meeting types, including: Type A, B and C for drugs and biologics, Type I, II and III for biosimilars, and INTERACT meetings for biologics. Regardless of which type of agency meeting you are preparing for - our regulatory experts can help.
Regulatory Agency Meeting Preparation
- Assist with writing questions in a way that is most likely to elicit beneficial answers from the agency’s review team
- Develop a briefing package containing sufficient information for the Agency to answer your questions
- Prepare the meeting logistics - list of attendees, submit questions in on time, etc.
- Assemble the meeting presentation and arrange practice run-through meetings, coaching attendees of how and when to speak