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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.
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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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Panacea combines an ex-FDA regulatory team with a specialized in-house AI platform to accelerate your FDA approval across 510(k), De Novo, PMA, IND, NDA and BLA pathways.
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Ex-AI Platform Engineer @ Anterior - backed by Sequoia, NEA and Microsoft AI's CEO. MS in AI from University of Illinois, Chicago. Ex-Software Engineer @ Bloomberg on the NoSQL data Infrastructure Team. Co-founded & bootstrapped Baqi, scaled to $5M+ in transactions with 20+ enterprise partnerships.
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