e-Dossier submission: Regulatory and Procedural Guidance

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The change to electronic format has also made matters more complicated. When businesses move to the online standard Electronic Common Technical Document (eCTD) format, they are gradually uncovering some burdens. eCTDs which fail to meet technical validation requirements can result in rejection by health authorities. Health authorities are raising the bar for reliable, compliant eCTDs because of pressure to meet deadlines for the process. The FDA has ordered almost all submission forms to be delivered in eCTD format starting from 2017. As well, other regulatory agencies are shifting to mandate eCTD delivery

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