Proven technology used by more than 35 authorities worldwide including EMA
Configure validation requirements to verify ECTD compliance
A scalable tool that supports parallel work between multiple users
The reviewing of electronic submissions upon receipt is a critical process for regulatory authorities.
EXTEDO's agency solution 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 within 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 EXTEDO technology 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.
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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 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 to 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.
“EXTEDO is a great example of a company that really understands the requirements of the market.”
Director Business Development, Technical Operations and international Business at Genericon
Your plan to effortless compliance
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Simplify your submission validation and reviewing processes and improve collaboration within your agency.
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. Designed to educate you on how to utilize your EXTEDO solution, our training sessions are conducted either in-house or onsite.
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.