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May 20, 2022 Agency Alerts

IRIS guide for applicants (How to create and submit scientific applications, for industry and individual applicants)


This guide has been produced to show applicants how to use the IRIS platform to prepare and submit an application and/or data for a scientific procedure (orphan designation application, scientific advice, ITF briefing meeting requests, marketing status reports, inspections and veterinary signal management) and related activities.

Download IRIS Guide for Applicants

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.



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