Your AI-Native FDA Regulatory Team
Backed by
Your AI-Native FDA Regulatory Team
Backed by
Half your timeline
to FDA Approval.
Half your timeline to FDA Approval.
Panacea combines an ex-FDA regulatory team with cutting-edge AI to accelerate your FDA approval across 510(k), De Novo, PMA, IND, NDA and BLA pathways.
Panacea combines an ex-FDA regulatory team with cutting-edge AI to accelerate your FDA approval across 510(k), De Novo, PMA, IND, NDA and BLA pathways.
About
About
World-class FDA consultants.
World-class FDA consultants.
We are a team of ex-FDA regulatory experts with over 50+ years of combined experience and hundreds of successful submissions across all FDA regulatory pathways, paired with our cutting-edge AI platform to transform how regulatory work gets done.
With milestone-based pricing and faster, higher-quality outputs, our incentives are fully aligned with yours — we deliver your innovations to patients significantly faster.
We are a team of ex-FDA regulatory experts with over 50+ years of combined experience and hundreds of successful submissions across all FDA regulatory pathways, paired with our cutting-edge AI platform to transform how regulatory work gets done.
With milestone-based pricing and faster, higher-quality outputs, our incentives are fully aligned with yours — we deliver your innovations to patients significantly faster.
Services
Services
How Panacea supports you.
How Panacea supports you.
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 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-Specific 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.
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 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-Specific 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.
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 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-Specific 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.
Why us
Why us
What makes us different
What makes us different
A unique blend of deep FDA expertise and AI engineers — we deliver results.
A unique blend of deep FDA expertise and AI engineers — we deliver results.
Faster Submissions.
Accelerated by a hypertuned AI platform, our consultants deliver results 10x faster.
Faster Submissions.
Accelerated by a hypertuned AI platform, our consultants deliver results 10x faster.
Fixed Cost — No Hourly Billing.
With fixed, milestone-based pricing — we align our quality & timeline incentives with your needs.
Fixed Cost — No Hourly Billing.
With fixed, milestone-based pricing — we align our quality & timeline incentives with your needs.
Testimonials
Testimonials
Here's what clients say
Here's what clients say
From clients we've supported and experts we've worked with.
From clients we've supported and experts we've worked with.
"Panacea’s platform has completely shifted the way I do my regulatory work. Due to the manual nature of the work, client engagements typically take weeks or months to deliver and, unfortunately, can be highly error-prone.
With Panacea’s platform, I have delivered client work 12x faster, and every output so far has been error-free, it's a huge competitive advantage."
Harun Sinha
Principal Consultant
"Panacea’s platform has completely shifted the way I do my regulatory work. Due to the manual nature of the work, client engagements typically take weeks or months to deliver and, unfortunately, can be highly error-prone.
With Panacea’s platform, I have delivered client work 12x faster, and every output so far has been error-free, it's a huge competitive advantage."
Harun Sinha
Principal Consultant
FAQs
FAQs
Common questions answered.
Common questions answered.
Find answers to the most common questions below. If you still have questions of your own, feel free to reach out directly!
Find answers to the most
common questions below. If you still
have questions of your own, just ask us directly.
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 guide you through a clear, milestone-driven project roadmap. Our AI-enabled team allows your team to move through the regulatory process significantly faster.
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.
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 guide you through a clear, milestone-driven project roadmap. Our AI-enabled team allows your team to move through the regulatory process significantly faster.
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.
Accelerate your FDA approval
Reach out and let’s explore how Panacea can support you.
Accelerate your FDA approval
Reach out and let’s explore how Panacea can support you.
Accelerate your FDA approval
Reach out and let’s explore how Panacea can support you.