DMFs in Health-Canada

Health Canada

DMFs in Health-Canada

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!

New QRD template released on EMA website
Spanish Notified Body 0318 Applies for EU MDR Redesignation

Este sitio web utiliza cookies para que usted tenga la mejor experiencia de usuario. Si continúa navegando está dando su consentimiento para la aceptación de las mencionadas cookies y la aceptación de nuestra política de cookies, pinche el enlace para mayor información.

Aviso de cookies