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How to Make Electronic Submission a Business Benefit

This article was originally published in SRA

Executive Summary

Many companies think of the electronic common technical document for submissions as a mere electronification of the CTD. They believe that implementing the eCTD essentially removes the printing processes while adding new processes for PDF rendition, bookmarking, hyperlinking and generation of the XML backbone. While this conception is not mistaken, it ignores important business potentials that the eCTD can offer a pharmaceutical company. Substantial business benefits such as reductions in submission times and costs could be achieved by companies if they approached the implementation of the eCTD as an opportunity to rethink their entire process hierarchy.

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