Prepare for the decisions that follow the meeting.
A valuable agency interaction begins with clear objectives: what guidance does your team need, and how will it influence development?
I help teams develop focused questions, present supporting evidence, and prepare for discussions with health authorities. After the interaction, I help translate feedback into practical actions.
How I Can Help
- Agency interaction strategy and meeting objectives.
- FDA INTERACT, pre-IND, end-of-phase, and other meeting preparation.
- International scientific advice planning.
- Meeting requests and briefing packages.
- Questions, scientific rationale, and proposed company positions.
- Cross-functional alignment and rehearsal sessions.
- Meeting participation and discussion support.
- Follow-up documentation and commitment tracking.
What You Receive
A meeting strategy, focused question set, briefing materials, preparation sessions, and a post-meeting action plan.