Outsourcing Your eCTD Project

Do you need to plan for outsourcing your eCTD project to meet the upcoming FDASIA eCTD mandates for NDAs, BLAs, ANDAs, and INDs?

IRISS-Forum Introduction

Implementation of Regulatory Information Submission Standards (IRISS) (pronounced ‘Iris’ – the flower) is conceptualized to be a global, open, multidisciplinary, non-profit organization dedicated to the implementation and widespread, successful adoption of electronic regulatory submission standards around the world.

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Please inquire about special considerations for members of BIOCOM.org. Contact us for more information.

GlobalSubmit

GlobalSubmit REVIEW and VALIDATE software for the FDA and for Life Sciences organizations around the world. Click here...

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