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Life Sciences Industry Facing New Challenges with the FDA's Latest Electronic Submissions Requirements

Companies filing electronic submissions must use new Electronic Common Technical Document (eCTD) format by Jan. 1, 2008. An integrated process for regulated content will help companies create, review, maintain and archive electronic submissions. Are companies ready?

The life sciences industry has long faced the difficult challenge of regulatory submissions, managing large volumes of required documentation and different rules across geographies. The industry's adoption of a new document standard, called the electronic common technical document (eCTD), promises to help companies improve the submissions process, shorten time-to-market and minimize costs. But according to recent analysis by Open Text™ Corp. (NASDAQ: OTEX, TSX: OTC), a global leader in enterprise content management (ECM), while the eCTD format can more than live up to its billing, many companies are unprepared for the looming Jan. 1, 2008 U.S. Food and Drug Administration (FDA) deadline to comply with the standard.

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