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EURSvalidator - EXTEDO's NeeS and eCTD Validator

The trusted technology for effortless eCTD and NeeS compliance.

Trusted by regulatory authorities across the world, including the European Medicines Agency (EMA), EURSvalidator is a validation software designed to ensure effortless eCTD, NeeS and vNeeS compliance through multiple subscription options.

EXTEDO’s EURSvalidator provides multiple subscription options for individual validation needs and enables users to configure their EURSvalidator subscription according to the country or region they want to file the submission. The validator enables users to combine different validation set packages within one package.

As the consulting partner of choice for more than 35 regulatory authorities worldwide, we ensure the greatest possible accuracy in managing your medicinal or veterinary eSubmissions.


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

Ensure compliance with regulatory requirements worldwide.

Up-to-date: Latest validation sets provided in timely manner.

Provides flexible subscription options for individual validation needs.

Available EURSvalidator modules

EURSvalidator uses a regional subscription model with packages of validation sets available depending on the country or region you want to file your submission within. Different validation set packages can be combined within one subscription. Currently, modules for the following regions are available:

  • EU North (Sweden, Norway, Denmark, Finland, Iceland)
  • EU West (France, Belgium, Netherlands, Luxembourg)
  • EU Central (Germany, Austria, Liechtenstein)
  • EU South (Spain, Portugal, Italy, Malta, Greece, Croatia, Slovenia, Cyprus)
  • EU East (Poland, Czech Republic, Slovakia, Hungary, Estonia, Latvia, Lithuania, Bulgaria, Romania)
  • EU UK & Ireland (United Kingdom, Ireland)
  • Group EU (EU North, EU West, EU Central, EU South, EU East, EU UK & Ireland)
  • Switzerland
  • Group North America (USA, Canada)
  • Group Asia Pacific (all member countries of the Gulf Cooperation Council (GCC), Australia, Japan, Jordan, Taiwan, Thailand)
  • South Africa (South Africa)
  • Vet Global
  • Group Global (all countries for which validation sets are currently available, incl. Vet

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Business Process and Regulatory Consulting Services

Tailored specifically to the needs of regulatory and related stakeholders, EXTEDO’s business process and regulatory consulting services are designed to support you during and after your eCTD submissions. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach.

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