From 1st September 2019, all new Master Files submitted to Health-Canada must be in eCTD format, in addition, when converting MFs from non-eCTD format to the eCTD format, the entire MF must be provided in the first eCTD transaction, as a baseline requirement.
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 [email protected]
Asphalion can support you!