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Results for: White Papers - Regulatory & Quality
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The Art of Compliance
April 21, 2011
The Art of Compliance is more than just meeting regulatory requirements for a new drug, biologic or medical device. It is the ability to elevate compliance beyond execution to achieve strategic advantage. Its insight-based solutions facilitate quick and appropriate response to repidly changing conditions. -
Clinical Endpoint Committees
February 22, 2011
As regulatory boards are expecting more from clinical endpoint committees, what guidance can you follow? This white paper sets forth current best practice for CECs. -
Managing Pharmacovigilance as a Business
July 28, 2010
The three steps required to develop a strategic approach to global capacity management. -
Regulations for Clinical Studies in Pediatric Patients in the European Union
March 10, 2010
After the United States issued pediatric drug study requirements, the European Union (EU) passed a regulation that created major changes to clinical studies for pediatric
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