The eCTD (electronic Common Technical Document) format is a specific electronic submission format for applications related to medicinal product marketing authorisations. It allows the optimal management of medicinal product dossiers and their life cycle. The content of the standard is based on the definitions of the CTD (Common Technical Document).
If a medicinal product is submitted in eCTD format, all subsequent submissions must also be made in eCTD format.
We take over the eCTD creation and maintenance (new marketing authorisations and lifecycle management) of medicinal product dossiers for you. On request, we also carry out publishing activities for Europe or other countries.
Your contact
Any questions? I would be delighted to answer them.
Christina Christen Regulatory Affairs and Quality Specialist/Publisher
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