Panacea
AI-native FDA regulatory services firm combining an ex-FDA regulatory team with a specialized in-house AI platform to accelerate FDA approvals across 510(k), De Novo, PMA, IND, NDA and BLA pathways.
About Panacea
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.
Products
AI-native FDA regulatory consulting service delivering expert-led strategy, end-to-end submission support, and FDA-trained AI tools across 510(k), De Novo, PMA, IND, NDA and BLA...
What customers say
Panacea reports supporting Acoustic Wave Cell Therapy’s 510(k) filing for its investigational pelvic-health device, combining FDA/CDRH expertise with AI-assisted research, evidence mapping, documentation and submission…
Case studyPerlumis Surgery engaged Panacea for the regulatory strategy of its AI urological-endoscopy software. Panacea reports developing FDA engagement and submission strategy, addressing pathway uncertainties early and…
Case studyAdialante engaged Panacea for its mobile MRI regulatory pathway. Panacea reports that its FDA experts and AI workflows shortened regulatory timelines by months, lowered costs relative to competing quotes and helped build…
Case study
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