Comparison

Regfo vs Qualio

Qualio is a cloud QMS — documents, training, CAPA, audit trail. Regfo is an AI compliance analyser — it reads your studies and tells you what is missing for IND. The two are complements more often than competitors: Qualio stores what you have, Regfo checks what you are about to file.

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Why this comparison comes up

  • A QMS implementation is the largest tool decision a regulatory team makes all year.
  • Qualio handles controlled documents but does not read your study PDFs.
  • You are filing an IND in weeks and need gap findings, not SOP hosting.

At-a-glance

DimensionRegfoQualioEdge
Job to be doneCompliance gap analysis on preclinical/IND packages.Controlled document, training, and CAPA management.Depends
Where AI appearsCore engine — extraction + rule checking.QMS workflows plus Compliance Intelligence (framework-level gap analysis, added 2025).Depends
Typical ACV$4.8K–$12K/yr (Pro/Team).Quote-only; third-party estimates ~$24K/yr (RepVue).Regfo
ICH/FDA citationsParagraph-level per finding (IND/drugs).Gap analysis mapped to frameworks (FDA QMSR, ISO 13485, ICH Q10); paragraph-level not documented.Regfo
SOP / training workflowsNot covered.Core strength.Them

Where the two tools actually differ

QMS vs compliance analysis

Qualio is the system of record for your quality processes — SOPs, training matrices, CAPA — and as of late 2025 it added Compliance Intelligence, which runs gap analysis against named frameworks like FDA QMSR, ISO 13485, and ICH Q10. Regfo works at a different altitude: it ingests your preclinical study reports and checks them against the specific ICH/FDA rules that gate an IND, returning each gap with the paragraph that triggered it. The two overlap less than it looks — Qualio centers on quality-system compliance, Regfo on drug/IND submission readiness.

Regfo

Answers "are my preclinical studies IND-ready?" with paragraph-level citations.

Qualio

Runs quality-system compliance plus framework-level gap analysis across GxP/device standards.

Pricing and decision window

Qualio does not publish prices — it is quote-only, and its pricing page notes an implementation fee applies to all plans. Third-party crowd-sourced data (RepVue) puts a typical deal around $24K/yr; treat that as an estimate, not an official figure. Regfo lives in the five-figure range ($4.8K–$12K/yr) with public, self-serve pricing. Many biotech teams use both — Regfo during the IND window, Qualio as the ongoing QMS once the company scales.

Regfo

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

Qualio

Quote-only; implementation fee on all plans. Third-party estimate ~$24K/yr (RepVue).

Speed to first insight

Implementing a QMS is a months-long project by design — you have to migrate SOPs, configure approval flows, map training. Running Regfo on a study report is a 30-second operation. If the immediate question is "what is going to get me a refuse-to-file?" the 30-second answer wins the week.

Regfo

Gap report, with citations, on day one.

Qualio

Full QMS value emerges over the first 60–90 days.

Pricing

Qualio is sold enterprise-style. Regfo is priced like SaaS a team can adopt without procurement.

Free

$0

1 workspace · 5 uploads · Phase 1

Pro

$399/mo

Unlimited uploads · Phase 1–3 + NDA

Team

$999/mo

10 seats · document generation · audit trail

Note on Qualio: QMS contracts commonly include implementation fees and per-seat user charges that exceed the license list price.

Pick Regfo if

  • Biotech preparing an IND in the next 1–6 months
  • Teams that need gap findings with citations, not SOP hosting
  • Companies that are not yet ready to absorb a full QMS contract

Pick Qualio if

  • Companies that need a system of record for SOPs, training, CAPA, and audit trail
  • Growing regulatory organisations formalising QMS ahead of commercialisation

Moving from Qualio to Regfo

What transfers

No handoff necessary — Regfo starts from your study reports, not from Qualio documents.

Manual steps

If you want to mirror your submission taxonomy, set up workspaces per indication or phase.

Support

Team-plan customers get custom onboarding; Pro customers get priority email support.

Frequently asked

Do I need to replace Qualio to use Regfo?

No. Many teams run Regfo alongside Qualio — Qualio as the QMS, Regfo as the compliance analyser during IND prep.

Can Regfo enforce SOP training?

No. Training management stays in a QMS like Qualio. Regfo focuses on the regulatory content of your submissions.

How does Regfo pricing compare to Qualio?

Regfo publishes its prices: Pro is $4.8K/yr and Team is $12K/yr. Qualio is quote-only with an implementation fee on all plans; third-party crowd-sourced data (RepVue) estimates a typical deal around $24K/yr.

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