EXTEDO. Redefining Regulatory Information Management.
  • eRA 2015 Conference, 01-02 July 2015

    Next Generation of Regulatory Information Management will be the motto of eRA 2015, which will be held in Munich, Germany. About 25 high-level experts from the industry and regulatory authorities will share their experiences and knowledge with you.

  • Regulatory Information Management

    The EXTEDOsuite is unique in that it covers the complete regulatory landscape including: product registration planning & tracking, submission management, pharmacovigilance management and document management.

  • Reviewing & Validation

    EXTEDOs reviewing and validation solutions EURS, GLOBALvalidator and EURSvalidator with their constant improvements and updates, always reflect the latest developments and help keep growing regulatory complexity under control.

  • Submission Publishing & Management

    eCTDmanager enables you to build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA, VNeeS, DMF, ASMF and other submission structures easily.

  • Happy customers make us happy!

  • XEVMPD Data Base System

    MPDmanager 2014 provides the functionality of a central product data repository and enables you to manage and maintain XEVMPD data efficiently and in compliance with current regulatory requirements.

EXTEDO Submission Reviewing & Validation Solutions

European Validation Sets (EU-eCTD, EU-NeeS, CH-eCTD)

Supports only the latest versions of the follwing validation sets:

  • European Union: EU-eCTD
  • European Union: EU-NeeS
  • Switzerland: CH-eCTD

Global Validation Sets (FDA-eCTD, FDA eCopy, CA-eCTD, MCC-eCTD, GCC-eCTD, JP-eCTD, KSA-NeeS, VNeeS, etc.)

Supports the latest and selected previous versions of the follwing validation sets:

  • USA: FDA-eCTD
  • European Union: EU-eCTD
  • European Union: EU-NeeS
  • Canada: CA-eCTD
  • Switzerland: CH-eCTD
  • Gulf Cooperation Council: GCC-eCTD
  • Japan: JP-eCTD
  • Kingdom of Saudi Arabia: KSA-NeeS
  • South Africa: MCC-eCTD
  • Veterinary: VNeeS

Bulk Validation

Up to 63 submissions can be validated in parallel.

Automated Validation

Full integration of validation in your workflow of submission processing.

Basic Functionalities
  • PDF reporting
  • Envelope viewing
  • DTD autoselector
Advanced Validation Functionalities
  • Fast validation sets
  • Q+A 36, best practice rules
  • Turn on/off validation sets (GLOBALvalidator only)
  • Turn on/off validation rules (GLOBALvalidator only)
Advanced Reviewing Functionalities
  • Document viewer (PDF, DOC, multi documents, etc.)
  • Regulatory activity view / Cumulative view / Current view
  • Document history / life cycle
  • Search in documents
  • User management
  • Add annotations
Review Like The Regulatory Authority

EURS is Yours is the validation, review and approval software solution for the EMA and over 25 Regulatory Authorities worldwide.

Technical Support not included e-mail only e-mail / telephone
Price free € 500 net per year on request
Download Buy now Contact us

 

 

 

Please note:

  1. GLOBALvalidator is based on EURSvalidator, but has additional capabilities.
  2. The setup file for EURSvalidator and GLOBALvalidator is identical.
  3. If enhanced functionality is required, EURSvalidator can be upgraded to GLOBALvalidator with a license file that has to be purchased at the EXTEDO Online Store.
  4. The download file (.zip) contains the setup file and all related documents.

 

 

 

Current Version of GLOBALvalidator / EURSvalidator

4.1

Release Date

26 January 2015

Comments

Please note that this version requires .NET Framework 4.0 which can be downloaded from Windows Update or here.

For further details see our Release Notes (included in the download package).