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Regfo

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Know exactly what FDA needs — before you submit. Regfo is an AI compliance platform for biotech teams preparing FDA submissions. Upload your preclinical study reports and protocols — Regfo checks them against more than 1000 rules from ICH/FDA guidelines and shows you exactly which requirements are missing, with citations. Built for small-to-mid biotech and CROs who can't afford to discover compliance gaps after submission. Replaces weeks of manual cross-referencing across ICH M3, S7A, S2, E6 and others. with a 3-minute automated gap analysis. Includes a free CTD Library with 218 regulatory sections mapped to IND Phase 1-3 and NDA requirements.

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