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

May 20, 2022

Computer generated 3D rendering of various file type icons.

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.

TAGS: EMA Europe IRIS Agency Alerts Regulatory Sciences

Related Articles

Medical information and data displayed on a tablet device.
Medical Information

July 3, 2023

Artificial Intelligence in the Medical Information Industry: Transforming Healthcare with AI and Automation

The rapid advancement of artificial intelligence (AI) technology has revolutionized various industries, including the medical information sector. One notable AI-driven tool is ChatGPT, developed by...

Continue reading the blog post
Medical Devices

September 20, 2018

FDA Grants Two Mobile Medical Applications to be Used with the Apple Watch

On Tuesday, September 11th, FDA granted two de novo classification requests for mobile medical applications to be used with the Apple Watch. ECG App The first app, referred to as the ECG app,...

Continue reading the blog post
3D rendering of a checkmark in a checkbox.
EMA

June 20, 2022

Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)

JUNE 2022 EMA/278419/2022-Rev.1 This validation checklist is used by the Agency to validate initial marketing authorization applications for pharmaceuticals and applicants should use it as a means to...

Continue reading the blog post