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About Regfo

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.