Health Authority Meeting Preparation
Maximizing the Value of Every Agency Interaction
Overview
Meetings with the FDA, EMA, or other health authorities are high-stakes opportunities to de-risk your program. We ensure you go in prepared. From drafting the briefing package to rehearsing the Q&A, we guide you through every step of the Pre-IND, End-of-Phase 2, or Pre-NDA meeting process to secure agency buy-in on your development plan.
Key Features
Our Process
Strategy Session
Defining the specific goals and questions for the meeting.
Document Preparation
Writing a compelling briefing book that frames the issues clearly.
Rehearsal
Rigorous practice sessions to ensure your team is ready for any question.
Frequently Asked Questions
Relevant Regulatory Guidance
Why Choose Us
- Clear agency feedback on critical issues
- Reduced risk of clinical holds
- Alignment on study design and endpoints
- Relationship building with reviewers
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Request a personalized consultation and detailed information about this service.
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Ready to get started?
Contact our team to discuss your specific needs for Pre-IND / Pre-CTA Meetings.
Schedule ConsultationWhat Our Clients Say
"The mock meeting sessions were invaluable. When the real FDA meeting happened, we were so well-rehearsed that even their tough questions felt manageable. We walked out with exactly the alignment we needed to move forward confidently."
Dr. Emily Watson
CEO
Early-Stage Biotech
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