Automated eCTD Validation Service
Validate eCTD Submissions in Seconds, Not Hours
Eliminate manual review errors with intelligent validation that checks every file, link, and specification against FDA, EMA, and ICH requirements.
Complete Validation Coverage
Every aspect of your eCTD submission validated automatically against the latest regulatory requirements.
XML Structure Validation
Automatic DTD validation, backbone integrity checks, and lifecycle operation verification.
PDF Compliance
Verify PDF version, font embedding, bookmark structure, and file specifications.
Hyperlink Verification
Test every internal and external link to ensure all references resolve correctly.
Regional Requirements
FDA, EMA, Health Canada, PMDA - validate against region-specific requirements.
Security Checks
MD5 checksum verification, virus scanning, and encryption detection.
Detailed Reports
Comprehensive validation reports with specific error locations and remediation guidance.
How It Works
From upload to validated submission in four simple steps
Upload
Drag and drop your eCTD package or connect to your document repository
Configure
Select target region and validation profile (FDA, EMA, or custom)
Validate
500+ automated checks run in seconds across all modules
Review
Get detailed reports with pass/fail status and fix recommendations
Ready to Eliminate Submission Errors?
See how DNXT Publisher can transform your regulatory workflow
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