Regulatory Agency Meeting Preparation & Support

Preparation is the key to ensuring a successful regulatory agency meeting.

When developing a product (drug, biologic, combination product) for approval - early and successful interactions with the FDA (or any regulatory agency) - can reduce both costs and time to approval. Developing a strong relationship with your product’s review division is crucial in ensuring that the Agency is knowledgeable about your product and supports the development pathway forward. Formal meetings with the FDA will strengthen this relationship and allow the Agency to provide input on your product and program's development plan.

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
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Regulatory Agency Meeting Attendance

  • Attend and facilitate the FDA meetings
  • Track FDA clinical, Non-clinical and CMC development requirements from pre-IND through to marketing application and beyond
  • Continual updates until final submission to regulatory agency – NDA, BLA, MAA, jNDA

Serve as Authorized Regulatory Representative and US Agent (pIND, IND, NDA, BLA)

 

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