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The trusted technology for 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 eCTD, NeeS and vNeeS compliance.
EXTEDO’s EURSvalidator provides multiple license options for individual validation requirements and enables users to configure their EURSvalidator license according to the country or region they want to file the submission. The validator enables users to combine different validation set packages within one license.
EXTEDO cooperates closely with regulatory authorities in order to guarantee that the relevant validation sets are included in the respective license packages and validation sets are up-to-date.
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. EURSvalidator uses a regional license 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 license.
- Trusted technology: 80% of regulatory authorities in Europe use EXTEDO technology (EURS) for ensuring eCTD and NeeS compliance.
- Flexible: Multiple license options for individual validation requirements
- Up-to-date: We ensure you always have the latest validation sets
- Expertise: EXTEDO is the consulting partner of choice for more than 35 regulatory authorities worldwide - Profit on the back of our success!
Available EURSvalidator modules
- EURSvalidator uses a regional license 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 license. Currently, modules for the following regions are available:
- EU North (Sweden, Norway, Denmark, Finland, Iceland)
- EU West (France, Belgium, Netherlands, Luxembourg)
- EU Central (Switzerland, 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)
- EU Unlimited (all EEA countries and EMA, all procedure types)
- Switzerland (Switzerland (without eDok)
- North America (USA, Canada)
- Asia Pacific (all member countries of the Gulf Cooperation Council (GCC), Australia, Japan, Jordan, Thailand)
- South Africa (South Africa)
- Global (all countries for which validation sets are currently available)
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.
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Education & Training Services
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
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