Assyro AI
eCTD v4.0 (RPS) validation

Validate your eCTD v4.0 sequence in seconds

Upload your RPS-based eCTD v4.0 package and instantly validate against ICH M8 schema requirements. Everything stays local on your machine.

  • ICH M8 eCTD v4.0 structural and schema checks
  • XML message validation, lifecycle operations, and metadata verification
  • Redacted structural summary you can export for internal QA

Ready for analysis

Drag a zipped dossier into the uploader to begin.

Why teams validate with Assyro

Built for compliance teams transitioning to eCTD v4.0 (RPS) submissions.

100% Private

Files never leave your browser. Zero server uploads.

Instant Results

Full analysis in under 60 seconds.

v4.0 Focused

RPS-based schema and XML message validation.

Secure

Client-side processing with no data retention.

Trusted validation methodology

Our v4.0 validator checks against official ICH M8 and FDA guidance documents. Every rule is traceable to its regulatory source.

ICH M8 eCTD v4.0 Specification
FDA eCTD Technical Conformance Guide
21 CFR Part 11 Compliance