We give pre-IND biotech teams the regulatory reasoning layer they can’t afford to hire.
A 20-person team without a dedicated regulatory hire shouldn’t need a $400/hr phone call to get a usable, auditable answer. Turtl.Bio is a structured interpretation workspace for FDA guidance and precedent, anchored to a specific product profile and sourced by construction.
- Customer
- Pre-IND US biotechs, < 50 people
- Stage
- Customer Interviews, Product Direction
- Sprint goal
- 15 structured discovery conversations, one pilot team
- Based
- New York
We expected drafting to be the bottleneck. It wasn't.
Our first framing was a broad Compliance and Regulatory Intelligence platform: pathway mapping, drafting, submissions, post-market surveillance. Discovery retired that framing.
“We expected drafting to be the bottleneck. Interviews revealed teams aren’t stuck writing. They’re stuck deciding what applies before they write anything.”
Intellectual honesty is a core operating principle.
Show evidence, not summaries
Every claim is tied to a specific interview, clause, or approval package. We show what we heard and from whom.
Name the scope, and the gap
We don't promise generalization to modalities we haven't tested. Today that means small molecules and radioligand therapies.
No replacing consultants
We sit between consultants and generic AI. Consultants own the high-stakes strategic work and are a distribution channel, not a target.
Built by a small team in New York.
Product, engineering, and outreach. Working directly with regulatory leads, founder-scientists, and CMC consultants to shape what gets built next.
Working on your first IND, or consulting for a team that is? Let’s talk.
We have a learning agenda, not a growth agenda. Honest signal is more useful than a sales pitch.
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