TLDR: Panacea hires elite FDA regulatory consultants, and pairs them with our AI platform, to deliver the fastest and lowest-cost pathway to FDA approval for Biotechs and MedTechs.

https://youtu.be/w1rudmd3cio?si=ft-e2f7QL_dBPxyj

About us

We’re Haris and Yaman. We have deep experience within enterprise AI for healthcare.

Previously, we both worked at Anterior (backed by Sequoia, NEA, Microsoft AI’s CEO) — where we built, sold and deployed our clinical AI platform to US health plans to remove major operational bottlenecks.

Haris (CEO) is an MD and led partnerships on Anterior’s GTM team (2nd GTM hire), selling to the biggest healthcare enterprises in the US and landed Anterior’s first health plan and partnership customers.

Yaman (CTO) has an MS in AI was an AI Platform Engineer, building and deploying Anterior’s clinical AI platform.

Now we’re doing the same for Life Sciences. Only this time, we’re not selling the AI tools. We’re owning the whole stack and selling the outcome. Faster, better and at lower cost.

Problem

Developing drugs and medical devices is complex and expensive (for drugs: 10-15 years, $1-2B).

The cost of drug development is growing exponentially (doubling every 9 years). This is known as Eroom’s Law (inverse Moore’s Law).

The most critical process in development is getting regulatory alignment, and ultimately, approval from the FDA.

Biotechs and medtechs outsource this work to regulatory consultants.

This work is highly manual: searching through legacy FDA databases, researching and reading hundreds of publications, reading FDA guidance documents, data analysis, authoring thousands of pages per filing, etc.

Consultants take months to years, and charge 6–7 figures per engagement, to deliver FDA regulatory strategy, authoring and submission services.

These consultants also price hourly. Therefore, using AI to go faster would cannibalize their revenue. So they have no incentive to deliver work faster.

What changed

AI can automate 90% of this work. Consultants can now focus on the 10% where their expertise and judgement is actually needed.

Solution

We hire the best FDA consultants in the industry (ex-FDA, decades of experience, hundreds of FDA filings).

We pair them with our AI platform to deliver higher quality FDA regulatory services significantly faster and at lower cost.

We also offer fixed, milestone-based pricing. Clients only pay once we deliver each agreed milestone.

Ask

If you know any biotechs or medtechs that need FDA approval, please feel free to connect us at haris@withpanacea.com! Also check out our website for more info: www.withpanacea.com