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5 search results for: eCTD modules

1

A closer look into the eCTD triangle and its modules

CTD is a well known term in the Life Sciences industry, and stands for Common Technical Document. This internationally agreed format contains a set of specifications developed by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the Ministry of Health, Labour and Welfare.

2

What’s next after eCTD?

Life sciences companies face enormous challenges to comply to the increasingly complex regulatory environments. More and more companies adopt the fully electronic eCTD submission format. In the meantime, the industry is already preparing for major revisions to the way in which information is provided to the health authorities. So, what is next and how will […]

5

Expansion to Japan thanks to eSA partnership

In recent years, the Life Sciences industry has been moving regulatory activities from paper based processes to fully digital. During this shift, they are facing enormous challenges to comply with the increasingly complex regulatory environment as more and more of the world adopts the fully electronic eCTD submission and other fully electronic formats.