Biotech teams spend weeks reviewing preclinical data against dozens of ICH and FDA guidelines before filing an IND. Regfo does it in minutes.

Upload your preclinical study reports — PDF or DOCX — and Regfo extracts key data: study type, species, GLP status, NOAEL/LOAEL values. It maps findings against ICH M3(R2), S7A/B, S2, and other applicable standards, then delivers a compliance score, detailed gap analysis, risk assessment, and prioritized action list.

The platform generates shareable reports for regulatory, project management, and CRO teams. No lengthy implementation — results from day one.

Regfo also includes a free, open-access library of 218 structured ICH/FDA regulatory sections organized by CTD module, covering every preclinical study type from single-dose toxicology to reproductive toxicology.

Regfo

Org chart

Teams

Offices