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    US Fundamentals of Regulatory Affairs, Ninth Edition

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    See the Agenda for Regulatory Convergence

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What can Regulatory Affairs do for Your Business?

“I see regulatory affairs as a strategic advantage for the business because it's an extremely complex subject. It's complex in terms of the data requirements to satisfy all the regulatory authorities, but it's also very, very complicated in terms of the number of product classifications. The companies which understand all the data requirements and all the complexities which exist are the companies that win in the long run.”
- Kenneth James, senior vice president, Research & Development
Consumer Healthcare, GSK


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RAPS and Regulatory

RAPS and Regulatory RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization.

Contact RAPS Global Headquarters

  • Regulatory Affairs Professionals Society (RAPS)
  • 5635 Fishers Lane, Suite 550
  • Rockville, Maryland 20852
  • P +1 301 770 2920 | F +1 301 770 2924
  • Email: raps@raps.org