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Taming the multi-headed compliance monster

A regulatory publishing solution is helping international biopharmaceutical company Cephalon deliver therapeutic products to the market more quickly.

Faced with mounting demands from regulators, the company wanted to enhance its large-scale regulatory submissions process, as well as its smaller, departmental report publishing capabilities. A developer of pharmaceuticals for neurological disorders, sleep disorders and cancer, Cephalon produces dossiers and large, complex documents that must comply with regulations in various countries in North America and Europe.

Mark Dameika, associate director of regulatory affairs at Cephalon, spearheaded the effort to replace the company’s manual publishing process with an electronic one--an effort that led to implementation of CDC Solutions EZsubs Team Edition software.

Like other small-to-midsize pharmaceutical companies, Cephalon didn’t need a huge document management system, but it did need the ability to publish business-critical reports and submissions. With the new software, coupled with QUMAS’ document management system, Cephalon can compile more of its submissions electronically in PDF format and paginate and “volumize” documents, easing regulatory compliance, according to CDC Solutions.

“We have realized considerable time and cost savings,” says Dameika, “Publishing various documents necessary for submissions now takes minutes or hours as opposed to other, less efficient methods that may have taken days, weeks or even months, depending upon the complexity of the project. The ability to utilize all of EZsubs’ output options--paper, CD-ROM or the Internet--has had a positive impact on the way our regulatory affairs business is conducted.”

With headquarters in Chester, PA, Cephalon employs 650 people in the United States and Europe.

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