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YC SP26 · Active

Panacea

AI-Native FDA Regulatory Services

Class
Spring 2026
Status
Active
Industry
Healthcare
Location
San Francisco, CA, USA
Team size
3

Website

https://withpanacea.com

About

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.