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EURS - Regulatory Agency eCTD Reviewing Software
The eCTD validation and reviewing solution the regulatory agencies like EMA choose.
Benefits
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.
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
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.
EURSnext product information
EXTEDO EURSnext is designed to simplify the view and review of regulated electronic submissions within authorities. It is browser-based, simple to deploy across your agency and requires minimal end-user training.
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.
Education & Training Services
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
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.