Regulatory Agency Interactions/Meetings
Ensuring a successful regulatory agency interaction requires expertise - our 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 authority or authorities can reduce both development 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.
That is why Veristat has assembled a team of scientific-minded regulatory experts to help you prepare for successful agency interactions, innovation office meetings, and scientific advice procedures.
Regulatory Interaction/Meeting Preparation, Attendance and Support
Regardless of which regulatory agency or authority you need to meet with, and what type of meeting you need supported, 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.