Different FDA pathways
Complizen and Regfo run the same idea — a vertical AI tool with built-in FDA knowledge and structured workflows — for two different FDA worlds. Complizen is for medical devices: device classification, predicate research, ISO 14971 risk files, and 510(k)/De Novo/PMA submissions. Regfo is for drugs and biologics: it reads your preclinical studies and checks them against the ICH guidelines and FDA rules that gate an IND. Neither is a substitute for the other. The question is which pathway you are on.
Regfo
Built for the drug/biologic IND pathway — preclinical gap analysis with ICH/FDA citations.
Complizen
Built for the medical-device pathway — 510(k)/PMA workflows and ISO 14971.
How each handles regulatory context
Both ship with the regulatory knowledge built in rather than expecting you to bring it. Complizen pairs ex-FDA device expertise with a knowledge base of guidance, predicates, product codes, and standards. Regfo parses 24 ICH guidelines and 1,054 rules into an engine that checks your study package and returns each gap with the paragraph that triggered it. If you are filing an IND, that paragraph-level citation is the part that saves a consultant hour.
Regfo
Every gap cites "ICH M3(R2) §1.6" or equivalent — verifiable against the source.
Complizen
Device-focused knowledge base: FDA guidance, predicates, product codes, standards.
Pricing model
Both tools publish self-serve pricing, which is unusual in regulatory software and good for emerging teams. Complizen lists a free tier plus paid plans and a custom Enterprise tier. Regfo lists a free tier, $399/mo Pro, and $999/mo Team. For a small team either is affordable — the deciding factor is pathway fit, not price.
Regfo
Free ($0), Pro ($399/mo), Team ($999/mo). 20% off annual. No setup fees, no implementation contracts.
Complizen
Published tiers: Free, Starter (~$66/mo), Pro (~$291/mo), Enterprise custom.