AI-powered Regulatory CMC, in days not months.

Panacea provides the first AI-enabled regulatory CMC team, with decades of expertise, to accelerate your CMC strategy, authoring and management.

No-Cost Consultation

how it works

25+ Years

of CMC Experience

About us

You do the science.

We handle the CMC.

Faster, better and fixed pricing.

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

CMC services delivered 10x faster

Our AI platform enables our CMC 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 CMC regulatory experience. Our AI platform ensures a highest quality with no gaps in your CMC 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.
CMC experts always in the loop.

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

01

Ingest

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

02

Draft

Elixir automatically authors and cross-checks consistency across all modules, enabling our team to move faster while maintaining FDA-grade quality. Authoring is owned and reviewed by experienced regulatory professionals.

02

Draft

Elixir automatically authors and cross-checks consistency across all modules, enabling our team to move faster while maintaining FDA-grade quality. Authoring is owned and reviewed by experienced regulatory professionals.

03

Verify

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

03

Verify

Elixir provides 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 CMC 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 CMC 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 compliant eCTD structure, consistency, cross-references, and supporting documentation are approval-ready.

05

Finalize

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

Customer Stories

We have a proven track record
with decades of CMC experience.

We have a proven track record
with decades of CMC experience.

Fast-Tracking an ADC Toward IND Clearance: From Asset Purchase to FDA Dossier in 9 Months
Supporting a Debut BLA Filing for a Cell & Gene Therapy Oncology Company
Execution of U.S. ANDA Filings Through a Domestic CRO Partner

Team Spotlight

Harun Sinha

CMC Regulatory Strategist

25+ Years Experience

Faq

Commonly Asked
Questions

Ask us directly

Is Panacea just another CMC 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?
Doctor working

Accelerate your CMC 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