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:

• Establish document data levels, authoring rules and practices that will support the drug throughout its life
• Integrate your regulatory strategies into eCTD design and lifecycle management
• Create one eCTD design that satisfies both U.S. and European regulators
• Build in the flexibility to re-purpose data for all the regulatory challenges a drug will face

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.

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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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