EURSvalidator

EURSvalidator is a submission validation tool developed by EXTEDO, designed to check the technical compliance of eCTD, NeeS, and vNeeS submissions against regional regulatory requirements before they are submitted to agencies. It is used by both pharmaceutical companies and regulatory authorities, with over 35 regulatory agencies worldwide relying on the same validation technology to assess incoming submissions.

The tool addresses common challenges faced by regulatory teams, including uncertainty around regional variations in submission standards, unreliable internal validation results, difficulty interpreting validation failures, and the complexity of keeping up with frequently changing global requirements. EURSvalidator is intended to reduce the risk of submissions failing at the agency level, which can cause significant delays in the review process.

Core Validation Capabilities

• Validates eCTD and NeeS submissions for technical compliance against regional regulatory requirements
• Supports vNeeS format validation in addition to eCTD and NeeS
• Used by over 35 regulatory authorities globally as their incoming submission validation tool
• Designed to provide the highest possible accuracy in validation results

Validation Set Management

• EXTEDO works directly with regulatory authorities to ensure all relevant validation sets are included in each regional package
• Validation sets are kept up-to-date on an ongoing basis, with updates provided in a timely manner
• Regional subscription packages are available, covering the specific country or region where submissions will be filed
• Different regional validation set packages can be combined within a single subscription

Workflow and Efficiency Features

• Supports simultaneous validation of multiple submissions, allowing all pending dossiers to be validated at the same time
• Reduces the need for repeated submission cycles by identifying compliance issues before agency submission

Onboarding Process

1. Schedule an initial call to discuss validation goals and challenges
2. Provide details about validation needs to receive a personalised quote
3. Begin using the tool to validate submissions prior to agency filing

EURSvalidator is part of EXTEDO's broader EXTEDOpulse platform, which also includes modules for document management, submission publishing, submission reviewing, and registration management. The tool is available with regional subscription packages that can be tailored to the specific markets where a company files submissions.