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.
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5 search results for: eCTD modules
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 […]
A regulatory submission for a Healthcare or Life Sciences product includes all sorts of documentation and information that is submitted to a regulatory agency for: review notification or in response to a request for additional information What are the types of formats of regulatory submissions? Paper submissions Non-eCTD electronic submissions (NEES) Electronic submissions with eCTD […]
We have been converting divergent documents into a unified format such as PDF for many years now. In knowledge-driven industries such as Life Sciences in particular, the need for standardization is highly motivated by the regulators. The introduction of the electronic Common Technical Document (eCTD) has accelerated the move from paper to electronic formats. And […]
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.