Will the electronic Common Technical Document (eCTD) submission you design today see your drug smoothly through its entire life cycle? Chances are it won’t — unless you make the right decisions now about everything from naming rules to authorship controls. Here’s where to start:
This new management report from FDAnews provides practical, proven guidance for designing eCTD-compliant product files today that will continue to make it easy to access and amend data files to satisfy regulatory purposes at any point in a drug’s lifecycle.
Avoid creating files that will require extensive rework down the road.
This guide will help you avoid mistakes that could eventually mean having to go back months — even years — to retrieve and reorganize all of a drug’s data files.
Instead, you’ll benefit from expert guidance on how to manage your data for maximum efficiency and regulatory utility right from the start, including how to:
As the eCTD standard is increasingly used by U.S. and international drug regulators, everyone in your company — compliance officers, medical writers, executives, IT personnel — can use this guide now to make the most of the advantages the eCTA format offers no matter what happens during a drug’s life cycle.
eCTD Submission Strategies: Optimizing Data for the Full Drug Lifecycle is available in print and PDF format for $377. Order your copy.
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