Regulated licensing · FDA · EMA · ICH E6

Licensing built for clinical operations teams.

Every tier processes documents locally in your browser sandbox. Start with a 1-week free trial — no document ever leaves the machine.

Clinical Trial Tier

For study leads and medical writers preparing individual protocol packages.

$249/ month per user

Single named user

  • Style & XML repair engine
  • Basic FDA layout validation
  • Data integrity matrix (up to 25 documents / mo)
  • Local-only sandbox processing
  • Email support, 1 business day

1-week free trial · no card required

Most selected

Institutional Tier

For clinical operations departments running parallel Phase II/III submissions.

$1,199/ month · up to 10 users

Up to 10 seats

Includes Downloadable PWA Desktop App

  • Unlimited documents & audits
  • Full ICH E6 (R3) structural auditor
  • Shared audit history across the department
  • Priority support with named CSM
  • 21 CFR Part 11 aligned audit trail export

1-week free trial · no card required

Enterprise Sovereign

For global pharma requiring advanced offline deployment and sovereign hosting.

Contact Salescustom global licensing

Unlimited seats · multi-region

  • Air-gapped / advanced offline deployment
  • US · UK · EU data residency controls
  • SSO, SCIM provisioning and role governance
  • Validation documentation pack (IQ/OQ/PQ)
  • 24/7 regulated-industry support SLA

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