The AI-native FDA regulatory team

backed by

Faster, lower-cost FDA Filings. Fixed pricing only.

Faster, lower-
cost FDA Filings.
Fixed pricing only.

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

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

Get in touch

Get in touch

Learn more

Who we are

The best FDA consultants in the industry.

We are a team of ex-FDA regulatory experts and AI engineers with decades of combined experience transforming how regulatory work gets done.

With milestone-based pricing and faster, higher-quality outputs, our incentives are fully aligned with yours — to deliver innovative therapies to patients significantly faster.

15+

Years spent at the FDA

60%

Faster than traditional firms

100%

Oversight by experts

Want to accelerate your FDA approval?

Book a free consultation

We support you throughout your development cycle, aligning our incentives with your goals.

Get in touch

Get in touch

Who we are

The best FDA consultants in the industry.

We are a team of ex-FDA regulatory experts and AI engineers with decades of combined experience transforming how regulatory work gets done.

With milestone-based pricing and faster, higher-quality outputs, our incentives are fully aligned with yours — to deliver innovative therapies to patients significantly faster.

15+

Years spent at the FDA

60%

Faster than traditional firms

100%

Oversight by experts

Want to accelerate your FDA approval?

Book a free consultation

We support you throughout your development cycle, aligning our incentives with your goals.

Get in touch

Get in touch

Who we are

The best FDA consultants in the industry.

We are a team of ex-FDA regulatory experts and AI engineers with decades of combined experience transforming how regulatory work gets done.

With milestone-based pricing and faster, higher-quality outputs, our incentives are fully aligned with yours — to deliver innovative therapies to patients significantly faster.

15+

Years spent at the FDA

60%

Faster than traditional firms

100%

Oversight by experts

Want to accelerate your FDA approval?

Book a free consultation

We support you throughout your development cycle, aligning our incentives with your goals.

Get in touch

Get in touch

Our customers

We support the next-generation of medical innovation.

Learn more about how we help deliver the latest medical innovations to patients significantly faster.

Panacea's ex-FDA experience and regulatory expertise has been invaluable. Their AI-powered approach has enabled us to move faster without compromising quality, all with fixed, risk-free pricing. It was a no brainer to choose them as our regulatory partner.

Efraín Torres

CEO, Adialante

Read more —>

ADIALANTE ᵀᴹ

Services

How Panacea supports you.

From strategy to approval, a unique blend of deep FDA expertise and AI engineers — we deliver results.

Expert-led Strategy

01

End-to-end Support

02

FDA-trained AI

03

Risk-free Pricing

04

Expert-led Strategy & Roadmap

Define the optimal regulatory pathway with expert consultants who have decades of experience and former FDA backgrounds, and build a clear, milestone-driven plan from current stage to approval/clearance.

Pre-Meetings to Approval

Consultants who have reviewed & delivered hundreds of FDA submissions drive the entire process, from pre- FDA meetings through end-to-end authoring and final submission, providing full expert support from start to finish.

Accelerated with FDA-trained AI

We pair experienced regulatory experts with our custom AI tools purpose-built for FDA regulatory workflows to compress timelines, automate manual work, and move significantly faster, while maintaining constant expert oversight.

Fixed, Risk-Free Pricing

No hourly billing. We work on fixed, milestone-based pricing—so you only pay when defined deliverables are completed. Aligned incentives, predictable costs, and zero risk on execution.

Get in touch

Expert-led Strategy

01

End-to-end Support

02

FDA-trained AI

03

Risk-free Pricing

04

Expert-led Strategy & Roadmap

Define the optimal regulatory pathway with expert consultants who have decades of experience and former FDA backgrounds, and build a clear, milestone-driven plan from current stage to approval/clearance.

Pre-Meetings to Approval

Consultants who have reviewed & delivered hundreds of FDA submissions drive the entire process, from pre- FDA meetings through end-to-end authoring and final submission, providing full expert support from start to finish.

Accelerated with FDA-trained AI

We pair experienced regulatory experts with our custom AI tools purpose-built for FDA regulatory workflows to compress timelines, automate manual work, and move significantly faster, while maintaining constant expert oversight.

Fixed, Risk-Free Pricing

No hourly billing. We work on fixed, milestone-based pricing—so you only pay when defined deliverables are completed. Aligned incentives, predictable costs, and zero risk on execution.

Get in touch

Expert-led Strategy

01

End-to-end Support

02

FDA-trained AI

03

Risk-free Pricing

04

Expert-led Strategy & Roadmap

Define the optimal regulatory pathway with expert consultants who have decades of experience and former FDA backgrounds, and build a clear, milestone-driven plan from current stage to approval/clearance.

Pre-Meetings to Approval

Consultants who have reviewed & delivered hundreds of FDA submissions drive the entire process, from pre- FDA meetings through end-to-end authoring and final submission, providing full expert support from start to finish.

Accelerated with FDA-trained AI

We pair experienced regulatory experts with our custom AI tools purpose-built for FDA regulatory workflows to compress timelines, automate manual work, and move significantly faster, while maintaining constant expert oversight.

Fixed, Risk-Free Pricing

No hourly billing. We work on fixed, milestone-based pricing—so you only pay when defined deliverables are completed. Aligned incentives, predictable costs, and zero risk on execution.

Get in touch

Team spotlight

Our experts are highly experienced and ex-FDA.

Dr. Jin Zhang, PhD, is a former FDA Lead Reviewer and Team Lead with a Bachelor's and PhD in Biomedical Engineering and Computer Science. Jin has both reviewed and supported hundreds of 510(k)s, Q-Subs, IDEs, De Novos, and PMAs, with experience across all device types. Jin has helped startups and public MedTech companies navigate U.S. regulatory pathways and secure FDA premarket clearances.

Dr. Jin Zhang, PhD

Principal Regulatory Affairs

Track record

Our team has supported complex devices through to approval.

We have authored and reviewed filings across all pathways and classes, from strategy all the way to approval.

Get in touch

Get in touch

PMA

Hepatic vascular radioembolization device

De Novo

Radiology AI diagnostic software

510k and DeNovo

First-of-its-kind biology-guided radiotherapy (BgRT)

De Novo

Mechanical circulatory support accessory

510(k)

Neurological surgical planning software

IDE

Radiofrequency ablation vs Radiotherapy clinical study for treating ventricular tachycardia

Why choose us

What makes us different

We are reinventing regulatory consulting with state-of-the-art technology to bring therapies to patients faster.

Other consultants

Other consultants

Other consultants benefit from slower delivery and unclear timelines — same manual work, more billable hours.

Panacea

At Panacea, we agree on a clear timeline, and work with speed and quality — only paid when we deliver the milestones.

FAQ

Your questions answered.

Everything you need to know about working with us. Still have questions? Book a free call and we'll walk you through it.

Is Panacea just another FDA regulatory consulting firm?

Panacea is different from all other FDA regulatory services out there. We combine deep FDA expertise with advanced AI technology to deliver faster, higher-quality regulatory outcomes. We work on a milestone basis—no upfront fees, and you only pay when agreed deliverables are met.

What does working with your team look like?

We start with a free consultation to understand your product and goals, then assign a dedicated regulatory lead supported by our AI platform to support you through a clear, milestone-driven project roadmap.

How does pricing work?

Unlike traditional consultants or CROs, we do not bill you hourly. Instead, we scope out the work, agree on milestones and timelines, and you only pay based on the delivery of each milestone. This structure aligns incentives and gives you clarity on cost and scope from the outset.

When should we engage with you?

You can engage with us at any stage of development—from early preclinical strategy to active FDA submission preparation or post-submission support. The earlier you engage with our team, the more we can accelerate your timelines.

What kind of companies do you work with?

We work with Life Sciences companies who are looking for fast and high quality FDA regulatory support to de-risk their FDA strategy and accelerate their path to FDA approval.

FAQ

Your questions answered.

Everything you need to know about working with us. Still have questions? Book a free call and we'll walk you through it.

Is Panacea just another FDA regulatory consulting firm?

Panacea is different from all other FDA regulatory services out there. We combine deep FDA expertise with advanced AI technology to deliver faster, higher-quality regulatory outcomes. We work on a milestone basis—no upfront fees, and you only pay when agreed deliverables are met.

What does working with your team look like?

We start with a free consultation to understand your product and goals, then assign a dedicated regulatory lead supported by our AI platform to support you through a clear, milestone-driven project roadmap.

How does pricing work?

Unlike traditional consultants or CROs, we do not bill you hourly. Instead, we scope out the work, agree on milestones and timelines, and you only pay based on the delivery of each milestone. This structure aligns incentives and gives you clarity on cost and scope from the outset.

When should we engage with you?

You can engage with us at any stage of development—from early preclinical strategy to active FDA submission preparation or post-submission support. The earlier you engage with our team, the more we can accelerate your timelines.

What kind of companies do you work with?

We work with Life Sciences companies who are looking for fast and high quality FDA regulatory support to de-risk their FDA strategy and accelerate their path to FDA approval.

FAQ

Your questions answered.

Everything you need to know about working with us. Still have questions? Book a free call and we'll walk you through it.

Is Panacea just another FDA regulatory consulting firm?

Panacea is different from all other FDA regulatory services out there. We combine deep FDA expertise with advanced AI technology to deliver faster, higher-quality regulatory outcomes. We work on a milestone basis—no upfront fees, and you only pay when agreed deliverables are met.

What does working with your team look like?

We start with a free consultation to understand your product and goals, then assign a dedicated regulatory lead supported by our AI platform to support you through a clear, milestone-driven project roadmap.

How does pricing work?

Unlike traditional consultants or CROs, we do not bill you hourly. Instead, we scope out the work, agree on milestones and timelines, and you only pay based on the delivery of each milestone. This structure aligns incentives and gives you clarity on cost and scope from the outset.

When should we engage with you?

You can engage with us at any stage of development—from early preclinical strategy to active FDA submission preparation or post-submission support. The earlier you engage with our team, the more we can accelerate your timelines.

What kind of companies do you work with?

We work with Life Sciences companies who are looking for fast and high quality FDA regulatory support to de-risk their FDA strategy and accelerate their path to FDA approval.