A closer look into the eCTD triangle and its modules

eCTD Triangle and 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.

What is the eCTD?

It is used for the preparation of applications for new drugs that need to be submitted to the regional regulatory authorities in all participating countries across Europe, Japan and the United States.

 

eCTD Triangle Modules Infographic

The paper CTD is destined to be replaced by the electronic version, called eCTD, and makes regulatory review processes easier.

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.

Interested to see how? Check our 30-min. webinar on how modern rendering saves time and reduces risk of non-compliance. See real-life examples from your peers and how Life Sciences companies of any size benefit from modern rendering technologies.

You can easily register below to access the recording.

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