January 2020 | EDQM will require eCTD submissions for all applications

January 2020 | EDQM will require eCTD submissions for all applications

As published in the Electronic submissions for CEP applications Revised Roadmap 2016-2020, from January 2020, EDQM will require eCTD submissions for all applications including requests for revisions and renewals (except for TSE only submissions and for submissions for substances for veterinary use only).

Asphalion has extensive experience with publishing in eCTD format. Our team is up to date with upcoming mandatory format and we can recommend according to timelines.

Any help you might need with the preparation of baselines, understanding the world of eCTD or choosing the right software, Asphalion would be more than happy to support you and make your eCTD journey both valuable and pleasant.

Please contact us at eCTD@asphalion.com

MDR | SSCP: a guide for manufacturers and notified bodies
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