Sage templates to be enhanced with content requirements detailed in FDA OGD completeness checklist for DMF-II for API submissions
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?
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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.