Industries · Pharma & Biotech
AI that passes
regulatory review.
We work with mid-cap pharma and growth-stage biotech teams on workflows that touch regulatory submissions, clinical reports, and medical affairs — where audit trails aren't optional and "move fast" can't mean "move sloppy".
Where we focus
Five workflows we've shipped or are shipping now.
Endpoint & CSR extraction
Structured extraction from clinical study reports with schema validation and expert-in-the-loop review.
Submission package QA
Automated cross-document consistency checks before submission packages go to the agency.
Protocol deviation triage
First-pass classification and routing of deviation reports across trial sites.
Literature monitoring
Daily synthesis of new publications against your therapeutic area and product portfolio.
Adverse event case processing
Structured ICSR narrative drafting with mandatory human review before submission.
CRO deliverable review
Automated pre-review of CRO-produced documents against your internal quality standards.
Controls we ship with every system
Built for GxP environments.
A document extraction pipeline, reviewed as if it were a person.
Mid-cap pharma. Endpoint extraction from clinical study reports. 90 days to production. 0 audit findings on the external regulatory review.
Read the case study →Let's talk
Start with a 30-minute call.
We'll walk through one workflow you've been trying to improve, and leave you with a concrete view of what a pilot would look like — whether you hire us or not.