Hi all - I’m Chetan, the founder of Rhizome AI.

Tl;dr

What has the FDA’s feedback been on real world evidence in review comments?

We help life science companies know what the FDA thinks.

Regulatory affairs teams ask a question and get an answer backed by terabytes of regulatory & clinical databases from the US, EU, etc.

Unlike ChatGPT, Rhizome reads up to 1,000 documents per question, accompanies each statement with a citation, and doesn’t hallucinate.

Ask: If you know any biotech or medtech leaders (esp if they’re regulatory affairs or R&D), I’d appreciate an intro!

Ultimately we want all reg affairs teams to be as informed as the most regulatory man in the world.

😖 The problem: Knowing what the FDA thinks

The FDA is the customer of every function in life sciences. It doesn’t matter whether you are regulatory affairs, R&D, quality, manufacturing, commercial, etc.

At the same time, it’s difficult to understand their thinking. Guidance documents are high level and vague. The only alternative is doing (or paying a consultant to do) manual, painful research on past decisions they’ve made and understand why. Other regulators around the globe are no easier.

ChatGPT / Claude / etc. have only made it worse

• They trust their knowledge and only look up what they feel the need to. This means low-latency, but high-hallucination research
• Even when they retrieve sources, at most, it’s a few dozen. It’s also liable to include lots of internet junk mixed in with the authoritative government databases the industry trusts
• They don’t make it easy to check citations. They cite a 1200 page PDF and you don’t really know where to dig inside it.

✨ The Solution: Hallucination-free, deep research for life sciences

Rhizome Ask solves this problem by providing hallucination-free and thorough deep research for the life sciences. There’s a few key things our customers like:

• We didn’t have a single hallucination reported in 2025.
• Every statement comes with a citation
• We read up to 1,000 documents per question in a few minutes before writing an answer. We’re continuously extending this limit.

Here’s a quick peek at the product:

Our customers love it. A few testimonials:

• “Last time we did this research, we spent weeks. Rhizome found the answer immediately.” - a VP of reg affairs at a clinical-stage biotech
• “Chetan idk what kind of magic you all did here, it’s so good” - a VP of reg affairs at a biotech with multiple products on the market
• “I would cry if I lost access to Rhizome” - an RA manager at a drug delivery device company
• “10 minutes of work can accomplish what would have taken weeks.” a device engineer at a pharma company

🤝 Who am I

A bit about my background.

I joined EvolutionaryScale as their first product engineer, launching an AI inference platform to help scientists design proteins. I joined Instabase as #16 helping banks with document & imaging processing, closing $7m as the technical lead.

When looking to start my own company, I realized we saw many AI startups focused on drug discovery, but a lot less attention bringing those products to market.

🙏 My ask: Connections with regulatory affairs, quality, or R&D leaders in life sciences

Do you know any regulatory affairs, quality, or R&D leaders in life sciences? It would be awesome to chat with them!

Other ways you can help:

• Follow us on Linkedin
• Share this post with your friends / family in life sciences!
• Learn more about us at rhizomeai.com