Panacea
AI-native FDA regulatory services: ex-FDA consultants paired with an AI platform, on milestone-based pricing.
Company basics
- HQ
- United States
- Founded
- 2026
- Team size
- 1-10
- Delivery model
- Managed (they run it for you)
- Pricing model
- Per project
Scope
- Industries
- HealthcareProfessional Services
- Regions
- United States
- Languages
- English (site only)
About Panacea
Panacea is an AI-native FDA regulatory services firm that combines an ex-FDA regulatory team with its specialized AI platform to accelerate approval across 510(k), De Novo, PMA, IND, NDA and BLA pathways, from strategy through FDA approval. Pricing is fixed and milestone-based, so customers pay when defined deliverables are completed rather than by the hour. The company is based in San Francisco, is part of the Y Combinator Spring 2026 batch and was founded in 2026. Its customer stories page lists work with Adialante, Acoustic Wave Cell Therapy and Perlumis Surgery and says clients complete regulatory work in weeks, not months.
What they do
Pricing
- Pricing model
- Per project
- Published starting price
- Not published
- Pricing page
- Not published
Evidence of outcomes
CNo publicly verifiable outcomes yet.Homepage and Y Combinator profile opened: San Francisco, Spring 2026 batch, 3 employees, founded 2026. No funding amount found, so funding is unknown. One customer-stories page lists three device and therapy companies without outcome data. Privacy and terms pages were not found as separate pages.
A: third-party verifiable outcomes · B: outcomes reported by the company or its investors · C: no publicly verifiable outcomes yet. Demos, forecasts and slogans do not count.
FAQ
What does Panacea do?
It provides FDA regulatory services for biotech and medical-device companies, pairing ex-FDA consultants with an AI platform.
Which pathways does it cover?
The homepage lists 510(k), De Novo, PMA, IND, NDA and BLA.
How is Panacea priced?
Fixed, milestone-based pricing: customers pay when defined deliverables are completed, with no hourly billing.
Where is Panacea based?
Its Y Combinator profile lists San Francisco and the Spring 2026 batch.
Our read
Editorial view based on public information — not an endorsement.
Capabilities
| Check | Status | Source |
|---|---|---|
| End-to-end delivery (you don't operate the tools) | Confirmed | Source · checked 2026-10-02Homepage: regulatory services from strategy through FDA approval. |
| Human review included | Confirmed | Source · checked 2026-10-02YC profile: experienced FDA consultants paired with an AI platform. |
| Signed off by licensed professionals (CPA, attorney…) | Not stated | — |
| Works inside your existing systems | Not stated | — |
| Private / on-prem deployment available | Not stated | — |
| API or data export | Not stated | — |
| Multilingual delivery | Not stated | — |
Commitments
| Check | Status | Source |
|---|---|---|
| Public delivery SLA | Not stated | — |
| Outcome-based pricing | Confirmed | Source · checked 2026-10-02Homepage: fixed milestone-based pricing; pay when defined deliverables are completed. |
| Refund / satisfaction guarantee | Not stated | — |
| Customer data not used for training | Not stated | — |
| SOC 2 | Not stated | — |
| ISO 27001 | Not stated | — |
| HIPAA | Not stated | — |
| GDPR | Not stated | — |
| Named party responsible for outcomes | Not stated | — |
Funding
Not disclosed
How we check
Every check below links to its source and shows when we checked it. "Not stated" means we found no public statement — it does not mean "no".
Other routes
Use a tool yourself
Get it implemented
Sources
- Company website: https://withpanacea.com/
- Human review included: https://www.ycombinator.com/companies/panacea
Change history
- 2026-10-02 · Listed on Toolsfine