01Index
The reasoning layer pre-IND biotech teams can’t afford to hire.
A structured workspace for interpreting FDA guidance and precedent against a specific product profile. Sourced and auditable by construction.
02Case Study
The problem, concretely
A prostate cancer drug. Do we need female-animal tox studies?
The answer lives in conditional FDA language and scattered precedent, not in a spreadsheet or a generic model.
Without Turtl.Bio
- D+0RA lead hits conditional FDA language in ICH S6(R1). No clear answer.
- D+2Digs through PDFs. Finds a competitor label but can’t access the full review document.
- D+4Calls a consultant at $300–500/hr. Gets “here are the considerations,” not a direct answer.
- D+7Decision delayed. Study planning stalls. Timeline slips.
With Turtl.Bio
Auditable interpretation. Sourced reasoning chain attached. Bring it to pre-IND.
“90% of what’s done is grey zone.”
05Delta
A generic model will always give you an answer. It won’t tell you when it’s guessing.
06Positioning
Where we sit
Too frequent for a consultant. Too consequential for a general model.
Turtl.Bio
Consultants
Turtl.Bio
Generic AI
07Customer
Who this is for
Founder-scientist or sole RA/CMC lead at a first-IND US biotech.
The person who is simultaneously the scientist, the strategist, and the regulatory lead, patching the gap with Google searches, scattered PDFs, and expensive consultant calls.
Company size
< 50 people
Stage
Pre-IND through first filing
Regulatory staff
0–1 dedicated hire
Budget today
$300–500/hr consultants
08Alpha
Working on your first IND? Talk to us.
We have a learning agenda, not a growth agenda. Honest product feedback is more useful than a sales pitch.
Request alpha access