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  • Our eCTD Services

    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 full electronic submissions standard for the European Medicines Agency, the U.S. Food and Drug Administration, Health Canada, and Swissmedic. Further countries are in different stages of implementing national specifications for the eCTD including Australia, Saudi-Arabia, South-Africa and Thailand (see our constantly updated News).

    Please find out more about our eCTD services:

    At Exalon, we understand our services not as an end to end business process with a "black box" in the middle but as an ongoing collaboration that includes a continuous knowledge transfer: learning from the external provider and learning from the client.

    For us, this means that we assure to always comply with the latest regulatory requirements, technology and data standards as well as agency recommendations - and we assure that your in-house team will comply, too.

    © 2007 - 2017 | Exalon GmbH | Fritz-Reichle-Ring 2 | 78315 Radolfzell | Germany | Phone: +49 (0)7732.939.1650 | Fax: -.1655 | e-Mail:info@exalon.com