EXTEDO. Redefining Regulatory Information Management.
  • Pharmacovigilance & Drug Safety

    PcVmanager is a drug safety management software solution based on the E2B and MedDRA industry data standards, that enables you to classify, create, review, submit, and maintain pharmacovigilance data and Adverse Event reports.

  • Regulatory Consulting

    EXTEDOs Regulatory Business Consulting (RBC) provides expert services to the life sciences industry by combining regulatory affairs knowledge, and technology to plan, compile, review, track and manage dossiers submitted to global regulatory authorities.

  • Reviewing & Validation

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

  • 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.

  • 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.

  • EXTEDO Events

    Visit our event page to see where you can meet the EXTEDO team or register for our upcoming webinars.

  • Free XEVMPD Data Viewer

    MPDviewer enables you to get your data records back from EVWEB, evaluate data, and generate reports. Request your access free of charge now at www.extedo.com/request

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, 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
  • 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

4.0

Release Date

06 June 2014

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).