Pharmaceutical Companies Nearing FDA Deadline

A recent article from PRWeb details the new Federal regulatory requirements facing the Life Sciences Industry. The industry’s implementation of a new document standard, called the electronic common technical document (eCTD), will require companies to capture all documents, variations, amendments and renewals in one consistent electronic format.

“Beginning January 1, 2008, the FDA will require that all electronic submissions to the Center for Drug Evaluation and Research (CDER) must use the eCTD format,” the November 27, 2007 PRWeb article stated.

The benefits of this new regulation include:

Minimizes costs

Shortened time-to-market

Time savings and efficiencies at the FDA

Visit our website to learn how our Enterprise Quality Management (EQM) can assist you in meeting these new FDA regulatory compliance reporting requirements.


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