Submission Management Hub - Publishing, Validation, Viewing and Reviewing of eCTD and other Regulatory Submissions

More than 35 regulatory authorities use EXTEDO to ensure eCTD and NeeS compliance

Ensure compliance with regulatory requirements worldwide

Reduce errors and increase productivity through advanced automation

EXTEDO's Submission Management Hub ensures effortless compliance globally

EXTEDO’s Submission Management software tools are designed to meet the needs of both the pharmaceutical and crop industry. They cover all global standards like eCTD or NeeS. We provide safe and compliant submission and lifecycle management software, which is essential for your business success in the fast-changing and highly regulated environment of these industries. All hubs provide you the greatest flexibility in designing your IT infrastructure on-premise or cloud-based.

EXTEDOpulse Submission Publishing

Build, view, validate, and publish compliant submissions based on CTD, eCTD v3, eCTD v4, NeeS, eCopy, IMPD, CTA, VNeeS, ASMF, and other submission structures

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EXTEDOpulse Submission Viewing

Reduce the complexity of viewing and reviewing archived and in-progress electronic submissions.

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EXTEDOpulse Submission Reviewing

A complete eCTD and NeeS validation and reviewing solution used by over 35 authorities worldwide, including EMA.

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EXTEDOpulse Submission Validation

Easily validate medicinal and veterinary electronic submissions with the validator that is used by over 35 authorities worldwide, including EMA.