Comparison

Regfo vs Harvey

Harvey is the category-defining AI for law firms — $11B valuation, most of the AmLaw 100, 500+ task agents with sentence-level citations. Regfo is not a Harvey competitor; it is the same idea pointed at a different domain. Harvey reads legal work; Regfo reads your preclinical package and checks it against 24 ICH guidelines and 1,054 FDA rules. If you wanted "Harvey, but for FDA submissions," that is the job Regfo does.

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Why this comparison comes up

  • You saw what Harvey did for lawyers and you want the equivalent for FDA regulatory work.
  • Harvey answers legal and regulatory questions broadly, but it does not check a tox study against ICH M3(R2).
  • Harvey is sold to firms on enterprise contracts; you want something a Series A team can start the same day.

At-a-glance

DimensionRegfoHarveyEdge
DomainFDA / ICH regulatory submissions for biotech.Legal and professional services — law firms, in-house counsel.Depends
Core approachVertical AI agents with paragraph-level citations.Vertical AI agents with sentence-level citations.Depends
FDA / ICH depth24 ICH guidelines, 1,054 rules. Every finding cites the section.Broad legal/regulatory coverage — not preclinical IND rule-checking.Regfo
Pricing & accessSelf-serve: Free · $399/mo · $999/mo.Enterprise contracts, sales-assisted, quote-only.Regfo
Scale & maturityFocused startup, ships weekly.$11B valuation, AmLaw 100, 500+ agents, 700K+ tasks/day.Them

Where the two tools actually differ

Same model, different domain

Harvey proved the thesis the whole industry now copies: take a regulated, document-heavy profession, build AI agents that know its rules, and make every output cite its source. Their April 2026 release added sentence-level citations and risk flagging — the exact feature regulated buyers demand. Regfo runs the same playbook for FDA submissions instead of legal matters. So this is less "which one wins" and more "Harvey for law, Regfo for the IND." A biotech team will not run their preclinical gap analysis inside a legal-research tool.

Regfo

The Harvey model — vertical agents plus citations — applied to ICH/FDA regulatory science.

Harvey

The benchmark for AI in law. If your problem is legal work, Harvey is the answer.

Regulatory depth on IND work

Harvey can research regulatory and compliance questions across domains, and it does it well. What it does not do is take your toxicology report and tell you that the hERG assay was not run under GLP, or that your repeat-dose duration falls short of ICH M3(R2) for your planned trial length. Regfo parses 24 ICH guidelines into a rule engine and checks the actual study package against them, returning a gap with the paragraph that triggered it. That is a different job than answering a legal question, even a regulatory one.

Regfo

Paragraph-level findings tied to the specific ICH/FDA rule, 46 data points extracted per study.

Harvey

Strong on legal/regulatory reasoning; not built to audit a preclinical package.

Pricing and who can start

Harvey is priced for firms and large enterprises — the model assumes high document volumes and a contract. That is the right shape for an AmLaw 100 buyer. It is the wrong shape for a ten-person biotech filing its first IND. Regfo lists every tier publicly, starts free, and tops out at $999/mo. You can test it this afternoon without procurement, which is the whole point at Series A.

Regfo

Free ($0), Pro ($399/mo), Team ($999/mo). 20% off annual. No setup fees, no implementation contracts.

Harvey

Enterprise, quote-driven. Built for firm-scale budgets, not self-serve.

Pricing

Harvey is enterprise and quote-only. Regfo publishes every tier and starts free.

Free

$0

1 workspace · 5 uploads · Phase 1

Pro

$399/mo

Unlimited uploads · Phase 1–3 + NDA · all modifiers

Team

$999/mo

10 seats · document generation · audit trail

Note on Harvey: Enterprise legal-AI contracts typically add seat minimums and onboarding services beyond the base license.

Pick Regfo if

  • Biotech teams who want "Harvey, but for FDA submissions"
  • Regulatory leads who need cited gap analysis on preclinical packages
  • Series A–C teams that need self-serve pricing, not an enterprise contract

Pick Harvey if

  • Law firms and in-house legal teams doing legal research, drafting, and review
  • Enterprises that need broad legal/professional-services AI at firm scale

Moving from Harvey to Regfo

What transfers

Nothing to migrate — these tools do different jobs. Teams that use Harvey for legal work can run Regfo for the regulatory submission in parallel.

Manual steps

Upload your study reports to Regfo directly; there is no legal-tool export step involved.

Support

Custom onboarding is included on Team. Pro teams get priority support.

Frequently asked

Is Regfo a Harvey alternative?

Only in the sense that both are vertical AI tools with citations. Harvey is for legal work; Regfo is for FDA/ICH submissions. A biotech team looking for "Harvey for regulatory" is looking for Regfo.

Does Harvey handle FDA IND submissions?

Harvey covers legal and regulatory questions broadly but is not built to check a preclinical package against ICH/FDA rules at the paragraph level. That is what Regfo does.

Is Regfo "the Harvey of biotech regulatory"?

That is the cleanest way to describe it. Same model — domain-trained agents plus source-cited findings — applied to ICH/FDA compliance instead of legal practice.

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