Sep 27, 2018

Automated solutions for eCTD baseline conversion

Transforming regulatory affairs processes just became one step easier with AI

For pharmaceutical companies and their regulatory affairs teams, 2018 heralds the end of Non-eCTD electronic Submission (NeeS) submissions for all European procedures (centralized, decentralized, and mutual recognition), with a mandatory requirement for submissions to be made in an electronic common technical document (eCTD). As of January 2019 the same will be required for all license updates to National Procedures.

Ensuring all submissions are now submitted via eCTD is due to the improved efficiency, compliance, and transparency in submissions. But the creation of an eCTD baseline can be challenging for many companies, as there are many factors they must take into account.

About the author

Claire Colville

Claire Colville

Assistant Vice President, Genpact Pharmalink

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