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.

Try Regfo freeSee pricing

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.Document workflows, not regulatory gap analysis.Regfo
Typical ACV$4.8K–$12K/yr (Pro/Team).$34K–$105K/yr (public deal data).Regfo
ICH/FDA citationsParagraph-level per finding.No — QMS is scope-agnostic.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 — that is where it belongs. Regfo is a different category entirely: it ingests your regulatory-relevant documents and compares them to the rules they must meet. It does not replace a QMS. What it does replace is a week of consulting hours and a stack of printed guidelines.

Regfo

Answers "are my preclinical studies FDA-ready?" with citations.

Qualio

Answers "where is my SOP?" and "did this person complete training?"

Pricing and decision window

Qualio ACVs land between $34K and $105K based on publicly reported deals. That buys you a full QMS. Regfo lives in the five-figure range ($4.8K–$12K/yr) because the scope is tighter. Many biotech teams use both — Regfo during the submission 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

Mid-market QMS pricing — expect $34K–$105K/year for a typical deal.

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 ACV compare to Qualio?

Regfo Pro is $4.8K/yr and Team is $12K/yr. Qualio deals public data ranges from $34K to $105K/yr.

Other comparisons

Regfo vs ComplizenRegfo vs Weave BioRegfo vs MasterControlRegfo vs Veeva Systems

Run your study package through Regfo — free.

1 workspace, 5 uploads, citation-level findings. No credit card.

Start free