FDA Meeting Consulting Services - Viltis
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FDA Meeting Consulting Services

FDA meeting consulting services support organizations preparing for and conducting formal interactions with the U.S. Food and Drug Administration. These meetings represent critical opportunities to align development plans with FDA expectations and reduce regulatory risk.

Effective FDA meeting preparation involves defining clear objectives, developing well-structured briefing documents, and formulating focused questions that address key regulatory uncertainties. Internal alignment across regulatory, clinical, quality, and CMC functions is essential to ensure consistent messaging.

Post-meeting activities are equally important, as FDA feedback must be translated into actionable development decisions.

FDA meetings commonly supported include:

  • Pre-IND meetings

  • End-of-Phase meetings

  • Type B and Type C meetings

  • Ad hoc regulatory discussions

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