AI-powered IND strategy & filings, in half the time.

Panacea provides the first AI-enabled Regulatory Affairs team, with decades of regulatory expertise, to accelerate your IND approval.

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how it works

25+ Years

of Experience

About us

You do the science.

We handle the filings.

Faster, better and guaranteed.

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

File submissions in half the time

Our Regulatory Affairs team uses our AI platform, Elixir, to move 10x faster. This reduces strategy and authoring timelines from months, to just days.

01
Highest quality, every time

Our team has decades of regulatory experience. Our AI platform ensures a high approval rate with no gaps in your final submission.

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-grade AI.
Experts always in the loop.

10x faster with healthcare-grade AI.
Experts always in the loop.

01

Ingest

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

01

Ingest

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

02

Draft

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

02

Draft

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

03

Verify

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

03

Verify

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

04

Review

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

05

Finalize

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

05

Finalize

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

Customer Stories

Our team has a proven track record with decades of experience.

Our team has a proven track record with decades of 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 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?
Doctor working

Accelerate your IND approval today.

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

Get in touch