Overview
Panacea is an AI-native regulatory-services team for medical products and life sciences.
What Panacea does
Panacea provides regulatory strategy and submission work for medical-device and life-sciences companies. Its team combines experienced regulatory professionals, including former FDA staff, with specialized AI tools for the documentation and coordination work.
An engagement begins with a product and development-stage assessment, followed by a regulatory roadmap and assigned lead. The published scope includes pre-submission meetings, authoring and filings across pathways such as 510(k), De Novo, PMA, IND, NDA and BLA.
Experts direct strategy and review outputs while the tools support preparation and repeated workflow tasks. The company uses defined deliverable milestones for commercial scope; neither the software nor a completed consulting milestone itself guarantees regulatory approval.
Differentiation
Regulatory delivery team
Clients engage professionals to develop and execute the regulatory plan, rather than purchasing a generic document-writing tool.
Milestone-linked scope
The proposed engagement ties fees to defined deliverables instead of billing only by time, while regulatory decisions remain with the relevant authority.
Pricing
Fixed, milestone-based engagements. The team agrees scope, milestones and timing, with payment tied to delivery rather than hourly billing.
Company details
- Headquarters
- San Francisco, California, United States
- Founded
- 2026
- Team size
- 3 (YC-listed team)
Founders & leadership
Investors & backers
Y Combinator
