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.
There's no risk when you purchase from FDAnews with our money-back guarantee. Not satisfied with your publication? Return the hard copy within 30 days (in resalable condition), and we will refund 100 percent of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.
Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.
Interested in Electronic Multi-user Access?
Phone: +1 (703) 538-7600 or toll free (888) 838-5578
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 – Fax (703) 538-7676 – Toll free (888) 838-5578.
Copyright ©2013. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing