eCTD Editor

Valid submission in accordance with ICH M2 EWG. M1 regional modules according to the specifications valid in EU (EMA) and also in USA (FDA).

"Using eCTD Editor is surprisingly easy. As we had basic documents for the first registration of the preparation already prepared, creating a valid submission in the eCTD format took no more than 15 minutes. Moreover, we do not have to worry about how the eCTD format keeps developing. Thanks to software support the program is always up-to-date."

- Marie Mery - Regulatory Manager, Biomedica, s.r.o.