Two years ago, the Committee of the Eurasian Economic Union (EAEU) released the standards for EAEU electronic submissions. From December 2020 all initial marketing authorization applications must be submitted in the new format. eCTDmanager already supports the new EAEU submission format.
We are pleased to inform you that EXTEDO’s EAEU test submissions generated with eCTDmanager have been tested and validated using the agencies' validators. EXTEDO not only offers EAEU in our software eCTDmanager, we can also offer publishing services and can build the submission for you.
And through those services we can offer help for working with the agencies' validators as well.
Whether you use our software and services or someone companies, We would recommend starting on your EAEU submission this year – well before the deadline next year.
Just contact us if you need support on EAEU submissions.