Regulatory Agency Meeting Preparation & Support

Preparation is the key to ensuring a successful regulatory agency meeting, our regulatory experts will help.

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
regulatory agency fda meetings

Regulatory Agency Meeting Attendance

You May Need an Authorized Regulatory Representative and US Agent

Our regulatory experts can help.  We represent biopharma for pINDs, INDs, NDAs and BLAs.

  • 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

Learn More with These Resources


Why and When to Hold a Pre-IND Meeting with FDA

While a pre-IND Meeting with the FDA is optional, the Regulatory team at Veristat highly recommends that all
drug developers planning to submit an IND to the FDA have a ...



Similarities and Differences Between the CTA and IND

Suppose the goal of a development program is to initiate clinical trials within European member states, the United Kingdom, or North America. In
that case, strategic ...


Case Study

First Gene Therapy Approved in Europe

Veristat was brought in to create and manage a full development program for a gene therapy for a very rare inherited disorder. The work involved charting the course in ...

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