BryNaxa eCTD Validator LIVE
Pre-flight an FDA electronic submission on your own machine, before it reaches the gateway, and catch the mechanical and technical defects that cause a rejection. It works fully offline, and every check is deterministic: the same submission always produces the same findings.
What it checks.
Validate your complete FDA eCTD submission before it reaches the gateway. BryNaxa eCTD Validator supports both eCTD v3.2.2 and v4.0, detected automatically, and reports every finding by severity so the sequence is clean before you submit.
Every finding cites the exact FDA rule, its published severity, and what to change — built from the FDA’s published requirements and kept current with FDA rule updates as requirements change.
- Folder structure, file naming, and every checksum in the package.
- XML validity against the official ICH schema.
- FDA controlled vocabulary — application types, submission types, headings, keywords.
- The study-data rules that trigger automatic technical rejection (ts.xpt, define.xml, dataset tagging).
- Document quality inside the PDFs: broken links and bookmarks, non-searchable pages, unembedded fonts, and document security.
Where it fits in the workflow.
Regulatory operations and publishing teams responsible for getting a sequence through the FDA technical gateway clean the first time. Run it at your desk before you submit — on the whole package, a single sequence, the reconstructed application lifecycle, or one document.
Everything stays on your machine.
Runs fully offline on your own Windows computer. No account, no cloud, no telemetry — your files never leave the desk. Every result comes from a published method computed the same way every time, so the same input always produces the same findings. You keep the report as a plain file in your own systems.
Capability by tier.
Try the full checks free: five complete runs of the sequence validation and five of the final-submission check, on your own real package.
We qualify. You validate.
This package provides the qualification documents and objective test evidence needed to validate BryNaxa eCTD Validator for your GxP use, and guides you through completing it. It does not itself validate your system. To reach a validated state, your organization must, under its own procedures: define and approve intended use and acceptance criteria; execute the IQ and OQ in your environment; execute the PQ using your own processes, data, and users; disposition any deviations; and have your quality unit review the completed evidence and approve it with handwritten signatures. BryNaxa provides the evidence; your quality unit makes the validated determination. This tool is not a 21 CFR Part 11 electronic-signature system; the signed record is the paper you print and wet-sign.
Download for Windows.
The free document checker is unlimited from first launch, and every paid tier includes free trial runs on your own files. For licensing, write to us and we’ll set you up.
Sources: FDA eCTD standards (v4.0) · FDA eCTD standards (v3.2.2) · FDA study-data standards & rejection criteria
Independent validation software — built from the FDA’s published requirements, running entirely on your computer.