From first draft to final submission.
Author clinical and regulatory documents — protocols, study reports, SOPs, and labeling — with structured review, full attribution, and an audit trail built for regulated work.
Every change is attributed to its author, including AI — a complete, exportable trail for inspections and audits.
Route documents through medical, regulatory, and QA review with structured, recorded sign-off.
Each revision is preserved and recoverable, with a clean history from first draft to filed document.
An audit trail for every line.
Sentence-level attribution across medical writers, reviewers, and AI agents — the provenance regulated work demands, ready to export.
No treatment-related serious adverse events were reported during the study.
Adverse events were coded using MedDRA version 26.0.
Two events were reclassified following medical review.
Controlled review
Structured sign-off across medical, regulatory, and QA.
Author tracking
Full, exportable provenance for every change, including AI.
Version history
Every revision preserved with a clean, inspectable history.
Document API
Generate submission-ready documents from approved content.
Talk to us about regulated workflows.
Enterprise plans add SSO, audit export, validation support, and custom retention. Authoring stays €99 per author — no base fee or minimum; usage-based generation and AI when you need them.