Life-sciences regulatory intelligence

Regulatory intelligence that reads your documents, not just your workflow.

AI-assisted compliance review and document control for quality teams, built by people who've supported the audits themselves and the remediation that follows an inspection.

There's a gap between "cheap" and "enterprise." Nothing sits in it.

Diagramming and workflow tools are inexpensive but have no compliance story. Enterprise QMS suites have the compliance story but cost ten times more than most teams need, and take a year to implement.

What you're stuck choosing between today

A spreadsheet, a SharePoint library, and a diagramming tool bolted together, with no real regulatory intelligence and no audit trail that holds up under inspection.

Or an enterprise QMS quote

A platform priced and implemented for organizations ten times your size, with a validation project attached before you see any value.

Findings that have been argued, not just flagged

Fifteen expert personas, one platform, one object model behind all of it. Nothing bolted on.

1

Fifteen personas, one verdict

A regulator, an inspector, and your internal reviewer, reimagined as agents that debate every finding to a reasoned, risk-weighted verdict before it reaches you.

2

Traceable, cited, audit-ready

Every finding anchored to the exact line of your document and the exact regulatory clause behind it, defensible long after the review.

3

Built for the regulated world

Part 11 by design, controlled documents managed end to end, and delivered with IQ/OQ/PQ validation coverage, not bolted on afterwards.

Live finding review inside a SOP, with every issue flagged, categorized, and ready to adjudicate
Live finding review inside your own SOPs: every issue flagged, categorized, and ready to adjudicate.

See how the full model works →

"Space reserved for a customer quote once we have one on record." Placeholder: swap for real customer material