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Frequently asked questions on the eCTD format (Part 1)

Frequently asked questions on the eCTD submission format (Part 1)

This article answers the most frequently asked questions on the electronic common technical document submission format. 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

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Why are leading life sciences companies rethinking their PDF rendering solution? 6 reasons.

6 good reasons why leading Life Sciences companies are rethinking their Document Rendering Solution

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

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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.

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