EURS - Regulatory Agency eCTD Reviewing Software

The eCTD validation and reviewing solution the regulatory agencies like EMA choose (customer list)

The reviewing of electronic submissions upon receipt is a critical process for regulatory authorities. Validating large numbers of submissions can quickly become a bottleneck, requiring a significant investment in both time and resources.
EXTEDO EURS is designed to simplify the validation and review of regulated electronic submissions within authorities. It provides you with tools for the validation, acceptance, import, review and maintenance of eCTD and NeeS-based submissions, giving you complete confidence that they conform to your official standard. EURS supports numerous regional agencies including EMA (with most local European NCAs), Swissmedic and other regions worldwide. 

EURS is also eCTD 4.0/RPS ready

As one of the NCA´s leading validation and reviewing solutions, numerous regulatory authorities use EURS to support their internal review processes. With periodic modifications to the ICH eCTD and Module 1 specifications, as well as ICH-developments and other changes introduced, EURS is continually updated to ensure that it remains at the leading edge.

Benefits

  • Quick access to submissions
  • Scalable solution supporting parallel work between numerous users
  • Advanced features for validation, import, display, search and printing
  • Extensive audit trail of user activities related to submissions
  • Powerful navigational tools and an intuitive user interface means minimal training
  • Proven technology used by more than 35 authorities worldwide
  • Configurable validation requirements to verify eCTD compliance
  • eCTD 4.0 / RPS ready
Intuitive user interface and self-explanatory icons - click to enlarge

Easy to deploy solution that integrates with third party systems

EURS is powerful, yet simple to deploy within your agency. Depending on your system specifications, EURS can be installed and validated within a matter of days. Its user-friendly and intuitive interface is equipped with an integrated, context-sensitive online help that ensures ease of adoption amongst your users, and minimizes the need for expensive structured training sessions. Supporting distributed workforces with many hundreds of users, EURS is also an extremely scalable solution.

To ensure a seamless connection into your existing processes EURS provides an API that enables you to readily integrate with many third-party systems. This ensures increased operational efficiency and further streamlines the validation processes within your organization. 

Automate validation processes and connect to EMA Common Repository

Communication with the EMA Common Repository (CR) is essential for optimized processes, and EURS is equipped with an integrated connector. Where required, its sophisticated CRconnector enables you to automatically keep a local EURS repository, or partial repository, that is synchronized with the EMA Common Repository.

Quick access to your relevant information by full text-search and filtering

Through the EURS interface you can access imported submissions and search, view, and annotate them. EURS powerful features allow you to organize and filter submissions based on certain criteria such as regulatory activities corresponding to the overall regulatory status of a drug product.

As recognized by regulatory authorities around the globe, EURS is the requisite solution for effortless review and validation of regulatory submissions.

EURSnext/eSUBmanager: view and review submission data directly within a web browser - click to enlarge
EURSnext/eSUBmanager: view and review submission data directly within a web browser

EURSnext – the web interface to EURS

If you need online access to previously submitted electronic dossiers, then EURSnext is the answer. EURSnext is the lightweight companion to EURS. It provides a fully functional reviewing system for agencies, enabling them to view and review submission data directly within a web browser. With no need for client software, EURSnext is the ideal solution for collaborative working between agency staff and external assessors where IT resources may be limited. EURSnext is a package based on eSUBmanager and is only available to regulatory authorities.

Downloads

EURS Product Information

EURS Services - Ensure that your NCA is eSubmission-ready today and for the future

  • Is your agency ready for the expected increase in volume of submission related data?
  • Are all your submission administration processes optimized and ready for future changes?
  • Are all of your legacy eSubmissions stored in your reviewing system?
  • Is your agency prepared for eCTD 4.0 / RPS?

As the trusted vendor to over 35 regulatory authorities, EXTEDO’s services team comes well-equipped with the knowledge and experience required to support your agency. At EXTEDO we understand the detail, including the technical challenges and procedural dependencies that are required to make your agency a successful regulatory business.

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Technical Consulting

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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