Solutions for Regulatory Agencies
As a leading provider of Regulatory Information Management solutions, EXTEDO has collaborated with regulatory agencies in order to ensure our solutions are compliant with the latest regulatory legislations. We provide software solutions to most European Regulatory Agencies and our products - EURS (EXTEDO Universal Review System) and EURSvalidator are used by over 35 regulatory agencies worldwide.
Solutions
- Submission Management (Validation and Reviewing)
Resources
EURS product information
EURS is the trusted solution for regulatory authorities such as EMA (with most local European NCAs), Swissmedic and other regions worldwide. EURS is one of the most comprehensive reviewing solutions for life sciences on the market.
EURSvalidator product information
EURSvalidator is used by over 35 authorities worldwide, including EMA, to ensure eCTD and NEES compliance. It enables you to easily validate medicinal and veterinary electronic submissions. EURSvalidator is available in several versions providing functionality and validation sets tailored to your region.