We support every phase of the FDA meeting lifecycle—from initial strategy through execution and follow-up—so you walk in prepared and walk out with clarity.
Before the Meeting: Strategy and Preparation
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Define meeting objectives and regulatory positioning
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Select appropriate meeting type (A, B, or C) and request strategy
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Draft, optimize, and format the briefing package
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Formulate high-impact questions that elicit actionable feedback
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Assemble supporting data and develop presentation slides
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Conduct mock meetings with internal stakeholders and SMEs
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Prepare your team for FDA tone, style, and likely discussion paths
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During the Meeting: Facilitation and Real-Time Support
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Attend and facilitate virtual or in-person meetings (if needed)
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Keep discussion on track and focused on sponsor priorities
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Capture real-time meeting notes and align team mid-discussion
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De-escalate miscommunications and clarify regulatory misunderstandings
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Provide real-time strategic counsel as new information emerges
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After the Meeting: Follow-Up and Alignment
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Draft and finalize meeting minutes that accurately reflect FDA guidance
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Identify and assign ownership for action items and commitments
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Support follow-up correspondence and clarification requests
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Translate feedback into submission or development plan adjustments
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Track agreement documentation and incorporate into regulatory strategy
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