Services

Regulatory Agency Interactions/Meetings

Executing a flawless regulatory agency interaction requires deep expertise – our global regulatory experts will help.

When developing a drug, biologic, medical device, IVD, or combination product for approval – early and successful interactions (meetings and written exchanges) with the appropriate regulatory authorities can reduce both costs and time to approval. Developing a strong relationship is crucial to ensuring that the governing Health Authority is well-informed and supports your planned development path.

Formal meetings or interactions with the FDA, EMA, MHRA, and other National Competent Authorities will strengthen this relationship and allow the Agency/Authority to provide input into your product and program's development plan. Our team of scientific-minded regulatory experts will help you prepare for successful agency interactions, innovation office meetings, and scientific advice procedures.

Ensure a successful regulatory agency interaction. Let’s Talk.

Veristat teams supported marketing applications for 8 therapies that received regulatory approval in 2022, the majority for therapies designed to treat rare diseases.

Regulatory Interaction/Meeting Preparation, Attendance, and Support

Regulatory authority meetings can help sponsors to (1) accelerate development and reduce costs, (2) clarify guidance and address unusual scenarios, and (3) minimize regulatory risk. Regardless of which regulatory agency or authority you need to meet with, and what type of meeting you need support for, our regulatory experts can help:

Request Meeting: Request meeting and prepare briefing package
Draft Questions: Assist with writing questions to elicit beneficial answers from the agency’s review team
Prepare logistics: list of attendees, submit questions on time, etc.
Practice: Assemble the meeting presentation and arrange practice run-through meetings, coaching attendees of how and when to speak
Attend: Regulatory Agency Meeting facilitation and/or attendance
Represent: Act as your Authorized Regulatory Representative or US Agent

Developing a strong relationship with your product’s review division is crucial to ensuring that the governing regulatory body is knowledgeable about your product and supports the development pathway forward.

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 always recommend working closely with FDA and can can help:

Determine type and timing of FDA meeting request
Develop a briefing package containing sufficient information for the Agency to answer your questions
Draft questions in a way that is most likely to elicit beneficial answers from the agency’s review team
Track FDA clinical, Non-clinical and CMC development requirements from pre-IND through to marketing application and beyond
Provide continual updates including annual safety updates until final submission to regulatory agency – NDA, BLA, MAA, jNDA

Innovation Offices are set up both by some European National Agencies and by the European Medicines Agency (EMA). These multidisciplinary groups provide advice on scientific and regulatory matters arising from the development of innovative Drugs, New Technologies and Borderline Products.

Interaction with the Innovation Offices usually takes place in the form of meetings. The EMA offers Briefing Meetings (BM) through the Innovation Task Force (ITF). Various National Competent Authorities (NCA) also offer this sort of interaction.

The BM at the EMA and meetings with some NCAs are free of charge and represent a valuable option for an initial planning of the best regulatory pathway that will successfully bring products onto the market.

Veristat has extensive experience in providing regulatory support to companies and academic groups during these meetings.

How We Help

Provide close regulatory support throughout the whole procedure
Ensure operational arrangements and interactions with the relevant Agency to set up meetings.
Prepare most important topics with the relevant Agency, thereby ensuring the best feedback to address the company’s concerns.
Define next steps and milestones, blending the Agency’s feedback with the company’s drug development planning.

A company can request Scientific Advice (SA) from the European Medicines Agency (EMA) or the National Competent Authorities (NCAs) at any stage of development.

SA helps to ensure the identification of appropriate studies in line with regulatory requirements so the advice may contribute to avoiding major objections during the evaluation of the Marketing Authorization Application (MAA).

Agencies provide SA by answering questions, which are usually related to quality, non-clinical, clinical and regulatory aspects of development.

How We Help

Prepare the logistics and all documentation required for the SA meetings and follow-up procedures.
Recommendations which regulatory Agency is the most appropriate for a particular case, and the timing to request the SA.
Attend and manage the meetings as the regulatory representative of the sponsors, if required.

Infographic: FDA Meeting Types: Timing, Purpose & Examples of Type A, B & C Meetings with CDER and CBER

Meeting with the FDA to discuss your development plans can help reduce both costs and time to approval. Download the infographic to learn about Type A, B & C meetings – with specific insights into meeting time, purposes, and examples of each type throughout development.

Ensuring a Successful FDA Meeting

Sponsors can implement several methods for ensuring a successful FDA meeting and developing a collaborative relationship. Veristat regulatory experts break down the values and types of FDA meetings and the importance of asking strategic questions with the appropriate background information for the most successful outcomes.

View the on-demand webinar to learn how to ensure a successful FDA meeting with the FDA >>

Get a copy of the webinar presentation here.