Regulatory Agency Services
Ensure that your NCA is eSubmission-ready today and for the future
In-depth process and technology analysis
When engaging our services, our technical and regulatory consultants provide you with an in-depth analysis of your existing processes and technologies. The result is an accurate assessment of the changes your agency needs to make in order to future proof your regulatory department and ensure ongoing success.
Tailored services for EURS
EXTEDO’s business process, regulatory and technical consulting services are tailored specifically to the needs of regulatory agencies. 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 EXTEDO Universal Review System (EURS) implementation approach for your specific submission flows – from receipt to review.
Benefits
Reduce downtime and increase effectiveness
Guarantee effective EURS maintenance
Ensure data quality via business & technical validation
Reduce the time and resources associated with the setup, administration and integration
Identify gaps in your business processes
Our time-tested approach is designed to help you plan your regulatory workflows; simplifying and structuring your processes and communications to align them with your system configuration and IT environment. EXTEDO’s team will help you to identify gaps in your business and regulatory processes and develop the appropriate strategies to eliminate them.
Our team provides the following services:
- Business process consulting
- Regulatory consulting to make your NCA successful using existing and new standards
- Gap analysis of data, storage and archiving
- Strategies for systems implementation and integration
- eSubmission data migration strategies
- Legacy submission data import
- Validation issue interpretation
- EURS portal integration service
- EURS update services
- Agency-to-industry workshops
Resources
EURS Services Information
Ensure that your NCA is eSubmission-ready today and for the futureulations.
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