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Regulatory Agency Services

Ensure that your NCA is eSubmission-ready today and for the future

As the trusted vendor to over 35 regulatory authorities, EXTEDO’s services team comes well-equipped with the knowledge and experience required to support your agency.

Is your agency ready for the expected increase in volume of submission related data?
Are all your submission administration processes optimized and ready for future changes?
Are all of your legacy eSubmissions stored in your reviewing system?
Is your agency prepared for eCTD 4.0 / RPS? At EXTEDO we understand the detail, including the technical challenges and procedural dependencies that are required to make your agency a successful regulatory business.

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

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