For some companies accustomed to paper submissions, the new electronic format was a challenge. The eCTD format is a change for the better, however, because it's a more efficient way for the reviewers to evaluate the submissions.
Regulatory submissions have always been a challenge in the life science industry. Previously, large volumes of required documentation and different geographical standards made submissions time-consuming and costly. The industry's adoption of the eCTD promised to improve the submission process, shorten time-to-market and minimize costs.
This white paper is especially valuable to life science companies still struggling with their online submissions. Gary Gensinger, Director of Regulatory Review Support Staff, Center for Drug Evaluation and Research (CDER) and CDER's Regulatory Information Specialist Ginny Ventura offer expert advice on creating successful submissions in an easy-to-read bulleted format. Their expert advice is in demand at life science conferences across the nation but you can get the benefit of their expertise free in this white paper.
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