Overview
We manage the entire lifecycle of your FDA interactions, from Type A meetings for dispute resolution to Type B milestone meetings and Type C guidance discussions. We ensure you ask the right questions and get the answers you need to proceed with confidence.
Key Features
Meeting type selection and timing
Briefing package strategy
Rehearsal facilitation
Minutes analysis and follow-up
Our Process
1
Preparation
Aligning your team and your data.
2
Execution
Leading the meeting with professionalism and strategy.
3
Documentation
Ensuring the official record reflects the discussion accurately.
Project Complete & Deliverables Provided
Frequently Asked Questions
Under PDUFA VII, there are five meeting types: Type A (critical path issues, clinical holds, post-Complete Response Letter meetings), Type B (milestone meetings like Pre-IND, End-of-Phase 2, Pre-NDA), Type C (specific guidance questions), Type D (narrow issues, fewer disciplines), and INTERACT (early development questions before IND). Each has different timelines and procedures.
Why Choose Us
- Clarity on regulatory expectations
- Documentation of agency agreements
- Risk mitigation
- Efficient program progression
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Request a personalized consultation and detailed information about this service.
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Schedule ConsultationWhat Our Clients Say
"Our End-of-Phase 2 meeting was make-or-break for our pivotal trial design. Adelphi's mock meeting preparation was so thorough that when FDA pushed back on our primary endpoint, we had three alternative proposals ready. We left with alignment on a path forward."
Dr. Katherine Yang
VP Clinical Development
Biotech Startup
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