Browser-based validation

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

Local onlyStep 1 · Upload

Drag & drop your entire dossier

We validate Modules 1-5, lifecycle XML, and checksum manifests right in your browser—no files ever leave your device.

Accepted: zip, 7z, tar, gz, gzip, xml, pdf · Drag & drop supported

Ready for analysis

Drag a zipped dossier into the uploader to begin.

Why regulatory teams choose our validator

Built for compliance teams who need fast, private, and accurate eCTD validation.

Files never leave your browser. Zero server uploads.

Full analysis in under 60 seconds.

v3.2.2 and v4.0 (RPS) dossier support.

Client-side processing with no data retention.

Our validator checks against official FDA, ICH, and CFR guidance documents. Every rule is traceable to its regulatory source.

FDA eCTD Technical Conformance Guide

ICH M8 eCTD v4.0 Specification

21 CFR Part 11 Compliance