✅ eCTD Validator

eCTD Validator performs complete technical validation of your eCTD submission package before gateway transmission — checking every PDF hyperlink, validating the XML backbone against FDA DTD specifications, verifying folder structure and file naming conventions, and producing a validation report that mirrors FDA's own gateway checks. Submissions that fail FDA technical validation are returned unfiled and the submission clock resets. eCTD Validator prevents that outcome.

Agent-Bound Tool — Included automatically with SubmitIQ and RegIntel agent subscriptions. Not available as a standalone product.

Tool Details

TypeAgent-Bound

SubscriptionWith SubmitIQ / RegIntel

CategoryCompliance and Validation

Data isolation✓ 6 layers

Audit trail✓ Immutable

This tool is included automatically when you subscribe to an agent that uses it. It operates inside the agent workflow and does not require separate subscription or configuration.

Features

What eCTD Validator does.

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PDF hyperlink validation

Checks every internal navigation link, cross-document reference, and bookmark in your eCTD PDF files — verifying that all hyperlinks resolve correctly within the submission package and that navigational bookmarks required by FDA guidance are present and functional.

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XML backbone structure validation

Validates your index.xml and regional XML files against the eCTD v3.2 and v4.0 Document Type Definition specifications and FDA and EMA backbone requirements — identifying structural errors, missing required elements, incorrect attribute values, and sequence numbering issues that would cause gateway rejection.

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Folder structure and file naming compliance

Verifies that your submission folder hierarchy, subfolder organisation, file naming conventions, and sequence numbering match the eCTD technical specifications for your specific application type — whether ANDA, NDA, BLA, or IND.

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Validation report generation

Produces a structured validation report listing every error and warning — with the specific file path, location within the file, validation rule violated, and FDA technical specification reference for each issue — in the same format as the docuBridge and eValidator reports that FDA's gateway produces.

Advantages

Why it matters.

Gateway rejections and restarted submission clocks eliminated

A submission rejected at the FDA Electronic Submission Gateway due to technical errors returns unfiled — resetting the submission date and adding months to the approval timeline. eCTD Validator catches every technical error before transmission.

Publishing team specialist time redirected from manual validation

Manual eCTD validation using publishing software requires specialist time and careful review. eCTD Validator automates the same validation in a fraction of the time — freeing publishing staff for review of findings rather than execution of checks.

Consistent validation standard applied across every sequence

Every submission sequence across your entire application portfolio is validated against the same comprehensive checklist — eliminating variation from manual review under different time pressures and by different team members.

Parallel validation of multiple submission sequences

For regulatory teams managing multiple ANDAs or submission sequences simultaneously, eCTD Validator runs validation in parallel across all sequences — removing the serialised validation bottleneck from pre-submission timelines.