Safeguarding Your eCTD Submission
Every sponsor organization would like to have a second verification of compliance before the submission is sent to
the agency, either via media or through the gateway. It is every sponsor’s goal to get it right the first time as any
issues found at the agency, minor or major, could delay the review and approval process. This means a delay in
patients’ and physicians’ access to new drugs as well as higher costs for the sponsor organization. Recognizing this
need, Datafarm developed eCTDGateKeeper to validate all eCTD submissions created by any software application.
Check and Double Check
Validation of an eCTD is a very critical step within the regulatory submissions process. eCTDGateKeeper is a stand-alone, eCTD validation software solution ideal for providing Regulatory and Quality Assurance teams with an autonomous eCTD validation process completely separate from whichever eCTD assembly tool that is in use. Having two levels of validation provides added confidence and reduced risks for delivering electronic submissions.
Multi-region Support
In addition to compatibility with all eCTD assembly tools, eCTDGateKeeper offers a multi-region compliant validation capability and support. eCTD standard adoption is growing every day. Agencies around the world are accepting and, in some cases, requiring submissions in eCTD format. Regional agencies are issuing their own validation criteria in addition to the ICH validation requirements.
eCTDGateKeeper offers a multi-region complaint
validation capability and supports the following:
ICH specifications:
- eCTD specifications
- ICH Study Tagging File (STF) specification
- Canada (CA)
- Europe (EU)
- Japan (JP)
- USA (US)
- Swiss (CH)
- Taiwan (TW)
Datafarm is committed to supporting any new region as the specifications become available.
eCTDGateKeeper Features
eCTDGateKeeper allows users to perform a complete or customized validation based on fully compliant validation rules. The following is just a sample of the features that eCTDGateKeeper provides:
- Validate directly from media
- Validate eCTD XML file(s) against the
ICH DTD
- Validate regional XML files(s) against the corresponding regional DTD provided
- Validate files and folders provided against XML backbone references
- Validate files provided in folder structure are referenced in the XML backbone files
- Verify PDF links and bookmarks
eCTDGateKeeper includes over 30 other validation rules that include ICH (Q36), and regional agency recommended validation rules.
Organizations cannot afford to take risks when the validity of a submission is critical to meeting compliance regulations – eCTDGateKeeper provides peace of mind at cost-effective price.
