Assyro AI
eCTD v4.0 (RPS) validation · Last updated

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.

How it works

Validate eCTD v4.0 structure before review starts

The tool is designed for RPS readiness checks without moving confidential dossier content out of the browser session.

  1. 1

    Upload the eCTD v4.0 sequence

    Drag a zipped RPS dossier, XML message, or supporting file into the validator. Processing stays local in the browser session.

  2. 2

    Run the v4.0 structure scan

    The validator checks ICH M8 structure, XML message validity, lifecycle operations, and metadata patterns for eCTD v4.0 readiness.

  3. 3

    Review prioritized RPS findings

    Findings are grouped by severity so publishing teams can resolve blockers before internal QA or agency submission.

  4. 4

    Export a redacted QA summary

    Use the redacted summary to coordinate remediation without exposing confidential submission content.

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