Regulatory Agency Interactions/Meetings
Prepare for Every Regulatory Interaction
Executing a successful regulatory agency interaction requires deep expertise – our global regulatory experts will help.
Early regulatory engagement can reduce both cost and time to approval.
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.
Ensure a successful regulatory agency interaction. Regulatory Agency Meeting Support – Defined
Regulatory agency meeting support covers the formal and informal interactions sponsors have with health authorities like the FDA, EMA, Swissmedic, MHRA and other national agencies throughout a product's development, including applications, meetings, written exchanges, and their associated briefing packages.
Veristat helps you figure out the right meeting type for your stage, prepare your briefing package and questions for the agency, develop company positioning, coach your team beforehand, attend the meeting and provide SME input as required, and follow up on next steps, so each interaction gives you clear, actionable guidance before you commit to your next development milestone.
WHY VERISTAT
Why Veristat for Regulatory Agency Interaction Meetings
Formal meetings or interactions with the FDA, EMA, Swissmedic, MHRA, and other National Competent Authorities will strengthen your relationship and allow the Agency/Authority to provide input into your product and program's development plan.
Veristat’s team of scientific-minded regulatory experts will help you prepare for successful agency interactions, innovation office meetings, and scientific advice procedures.
How It Works
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:
01
Request Meeting
Request meeting and prepare briefing package
02
Draft Questions
Assist with writing questions to elicit beneficial answers from the agency’s review team
03
Prepare logistics:
List of attendees, submit questions on time, etc.
04
Practice
Assemble the meeting presentation and arrange practice run-through meetings, coaching attendees of how and when to speak
05
Attend
Regulatory Agency Meeting facilitation and/or attendance, including SME input as required
06
Represent
Act as your Authorized Regulatory Representative or US Agent
FDA Meetings
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.
FDA meetings
The FDA offers several formal meeting types, each suited to a different stage of development:
Type A meetings
Reserved for urgent situations, such as resolving a clinical hold or addressing a dispute. The FDA is required to respond quickly, typically within 30 days of the request.
Type B meetings
The most common type, held at key development milestones like pre-IND, end-of-Phase 2, or pre-NDA/BLA, to align on your development and submission plans.
Type C meetings
Cover any other topic not addressed by Type A or B, such as early discussions on a novel endpoint or biomarker strategy.
INTERACT meetings
An early, informal opportunity (typically pre-IND) for biologics sponsors to get FDA feedback before a formal meeting request, often used to de-risk a novel product's early development strategy.
Type I, II, and III meetings
The biosimilar equivalents of Type A, B, and C meetings, following the same urgency-based framework for biosimilar development programs.
EMA Innovation Offices Meetings
- Innovation Offices have been established by some European National Agencies (NCAs) 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 EMA Briefing Meeting 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 experience in providing regulatory support to companies and academic groups during these meetings.
EMA and NCAs Scientific Advice (SA) Meetings
- Companies can request Scientific Advice (SA) from the European Medicines Agency (EMA) or the National Competent Authorities (NCAs) at various stages of product development.
- SA can help companies identify appropriate development program steps and studies that are aligned with regulatory expectations. Early regulatory input may help reduce the risk of major issues arising during the evaluation of a Marketing Authorization Application (MAA).
- Agencies provide SA by responding to specific questions and company positions provided by the MA applicant. These questions can cover quality, non-clinical, clinical and regulatory aspects of product development that require clarification.
NEXT STEPS
What's Next in the Drug Development Process
Regulatory Consulting.
Apply our knowledge and insights to plan and implement regulatory strategies for successful interactions with Regulatory Agencies.
Marketing Applications.
We help prepare, write and defend your marketing applications with the global regulatory agencies.
Medical Writing.
We write clinical trial and regulatory documents tailored to meet the specific requirements of the product, therapeutic indication, and regulatory agency.
PROOF & RESOURCES
Real Programs, Real Outcomes
FDA Meeting Types: Timing, Purpose & Examples of Type A, B & C Meetings with CDER and CBER
Download →
Ensuring a Successful FDA Meeting
Watch Now →
Have a regulatory agency meeting coming up? Let's make sure you're ready.
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:
Frequently Asked Questions
Regulatory agency meeting support covers the formal and informal interactions sponsors have with health authorities like the FDA, EMA, Swissmedic and MHRA throughout a product's development, including meetings, written exchanges, and briefing packages. It is designed to give sponsors clear, actionable guidance on their development plan before committing time and resources to the next stage.