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What Keeps Regulatory Professionals Up at Night?
December 17, 2006
Three things: Concerns about Compliance, Staffing, and Knowledge.
But what are these potential problems and why is it so important to understand them? Ultimately, the problems impact the business in 1 of 2 ways: increased costs brought on by fines or inefficiencies OR decreased revenues because new products are not approvable as quickly as possible or existing approved products are not maximized for distribution in the marketplace. Overarching all of this is the general frustration that the "rule book" that these companies have to "play by" is one that has been imposed upon the regulatory affairs professional by many outside/external organizations - specifically, the world's many and diverse regulatory authorities responsible for approving new drugs for sale in their geographies.
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