EURS - Regulatory Agency eCTD Reviewing Software

The eCTD validation and reviewing solution the regulatory agencies like EMA choose

The reviewing of electronic submissions upon receipt is a critical process for regulatory authorities.

EXTEDO EURS provides you with tools for the validation, acceptance, import, review and maintenance of eCTD, NeeS-based and non-eCTD submissions, giving you complete confidence that they conform to your official standard.

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 with authorities. With validation, review, approval, maintenance and importing tools, EURS is the solution of choice for many regulatory agencies around the world.

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 cutting edge.

A scalable tool that supports parallel work between multiple users

Advanced features for validation, import, display, search and printing.

Proven technology used by more than 35 authorities worldwide including EMA.

Configurable validation requirements to verify eCTD compliance

Easy to deploy, swift to scale.

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 an extremely scalable solution.

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Integrates effortlessly with third-party software

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. In addition to this, EURS’ integrated connector enables you to automatically keep a local EURS repository, or partial repository, that is synchronized with the EMA Common Repository.

Quick access to relevant information by text-search and filtering

Through the EURS interface, you can access imported submissions and search, view, and annotate them. This powerful feature allows 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 – 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 browser-based package based on eSUBmanager and is only available to regulatory authorities.

Resources

Services

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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