How to cut time and cost by re-using already submitted documents. Increasing drug-development costs, patent expirations, and fewer blockbuster drugs in the pipeline are forcing life-science companies ...
All regions that have published guidelines will mandate implementation of eCTD version 4.0 by 2028, with more regions to follow in the future Developed by the International Council for Harmonisation ...
In 2005, the heads of the European medicines agencies agreed that all EU member states must have the infrastructure and processes in place to handle only electronic Common Technical Document (eCTD) ...
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