Know if your sequence is submission-ready in under 60 seconds
Upload your eCTD sequence and instantly see every structural issue while every document stays local on your machine.
- 358 CFR, ICH, and FDA TRC structural checks across Modules 1–5
- Lifecycle operations, hyperlinks, metadata, and checksum manifests validated locally
- 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 structure before review starts
The tool is designed for quick submission-readiness checks without moving confidential dossier content out of the browser session.
- 1
Upload the eCTD package
Drag a zipped dossier, XML sequence, or supporting file into the browser-based validator. Files are processed locally and are not uploaded to Assyro servers.
- 2
Run the structure scan
The validator checks module structure, lifecycle operations, hyperlinks, metadata, and checksum manifests against FDA, ICH, and CFR-aligned rules.
- 3
Review prioritized findings
Findings are grouped by severity so regulatory operations teams can triage blockers before internal QA or agency submission.
- 4
Export a redacted QA summary
Use the redacted summary to document structural readiness and coordinate remediation without exposing submission content.
Why regulatory teams choose our validator
Built for compliance teams who need fast, private, and accurate eCTD validation.
100% Private
Files never leave your browser. Zero server uploads.
Instant Results
Full analysis in under 60 seconds.
Comprehensive
v4.0 (RPS) dossier support.
Secure
Client-side processing with no data retention.
Trusted validation methodology
Our validator checks against official FDA, ICH, and CFR guidance documents. Every rule is traceable to its regulatory source.