Your AI-powered
FDA Regulatory team.

Panacea combines cutting-edge AI with an ex-FDA regulatory team to accelerate your FDA approval across 510(k), De Novo, PMA, IND, NDA and BLA pathways.

No-Cost Consultation

how it works

About us

You do the science.

We handle the filings.

Faster, better and fixed pricing.

You do the science. We handle the filing. Faster, better and guaranteed.

Regulatory services delivered 10x faster

Our AI platform enables our regulatory team to to deliver 10x faster, reducing strategy and authoring from months, to just days.

01
Highest quality, every time

Our team has decades of regulatory experience. Our AI platform ensures highest quality with no gaps in your regulatory strategy.

02
Pay for outcomes, not hours

No payment upfront, no hourly billing. We price on value provided, and you only pay when we deliver on mutually agreed milestones.

03

how it works

10x faster with healthcare-native AI.
Regulatory experts always in the loop.

10x faster with healthcare-native AI.
Regulatory experts always in the loop.

01

Ingest

Our AI Platform structures and cross-references your product data against FDA and ICH guidance, instantly revealing gaps, risks, and missing data to our experts.

01

Ingest

Our AI Platform structures and cross-references your product data against FDA and ICH guidance, instantly revealing gaps, risks, and missing data to our experts.

02

Draft

Our platform automatically authors and cross-checks consistency across your regulatory dossier, enabling our team to move fast while maintaining FDA-grade quality. Authoring is owned and reviewed by experienced regulatory professionals.

02

Draft

Our platform automatically authors and cross-checks consistency across your regulatory dossier, enabling our team to move fast while maintaining FDA-grade quality. Authoring is owned and reviewed by experienced regulatory professionals.

03

Verify

We provide exact citations to the original source data, ensuring easy expert verification, auditability, and confidence in every output.

03

Verify

We provide exact citations to the original source data, ensuring easy expert verification, auditability, and confidence in every output.

04

Review

Using expert review and AI-assisted verification, we stress-test your regulatory strategy and data against FDA expectations and resolve issues fast, not in response to an FDA hold or information request.

04

Review

Using expert review and AI-assisted verification, we stress-test your regulatory strategy and data against FDA expectations and resolve issues fast, not in response to an FDA hold or information request.

05

Finalize

Our team prepares your FDA filing for submission, ensuring FDA compliant structure, consistency, cross-references, and supporting documentation are approval-ready.

05

Finalize

Our team prepares your FDA filing for submission, ensuring FDA compliant structure, consistency, cross-references, and supporting documentation are approval-ready.

Faq

Commonly Asked
Questions

Ask us directly

Is Panacea just another FDA regulatory consulting firm?
What does working with your team look like?
How does pricing work?
When should we engage with you?
What kind of companies do you work with?
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Accelerate your FDA approval today.

Get in touch today to discuss your needs, timelines, and how we can work together to fast-track your FDA approval.

No-Cost Consultation Today