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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“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
Schedule a call
We’ll discuss your goals and uncover your challenges with validating and reviewing electronic submissions.
Get a free consultation
Our experienced business and technical team will outline a solution to solve your challenges.
Reduce your assessment timelines
Simplify your submission validation and reviewing processes and improve collaboration within your agency.
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.
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.