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Life Sciences Industry
Facing New Challenges
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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