Panacea

YCombinator Backed

AI-Native FDA Regulatory Services

Panacea provides AI-native FDA regulatory services for Biotechs and Medical Device companies. We hire the most experienced FDA consultants in the industry (ex-FDA, decades of experience, hundreds of filings) and pair them with our AI platform to enable the fastest and lowest cost pathway to FDA approval. While other regulatory consultants bill hourly, our pricing model is simple: fixed, outcome-based pricing. Payment is only due when milestones are complete. We support all FDA regulatory pathways including IND, NDA, BLA, ODD, Pre-Subs, 510(k), De Novo, PMA, IDE, BDD, etc.

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