Electronic respectively eCTD submissions are increasingly recommended - and requested. All national drug regulatory agencies in EU/EEA are accepting electronic submissions for medicinal products for human use and are recommending the eCTD as the preferred standard. Furthermore the, eCTD serves as the only electronic submissions standard for the European Medicines Agency, the U.S. Food and Drug Administration, Health Canada, and Swissmedic. Further countries are currently developing national specifications for the eCTD (see our constantly updated News).
Please find out more about our eCTD services:
We understand our services not as an end to end deliverable with a "black box" in the middle but as an ongoing collaboration and as a continuous knowledge transfer. For us, this means that we assure to comply with the latest regulatory requirements and agency recommendations - and we assure that your in-house team will comply, too.