Laws and Regulations: The Discipline of Regulatory Affairs
The discipline of regulatory affairs integrates the scientific information obtained during the development of a drug product, the marketing opportunities and competitive landscape, protection of the intellectual property surrounding a drug product, and the compliance efforts of a pharmaceutical company. It requires knowledge and, most importantly, interpretation of the most current requirements of regulatory authorities around the world.
KeywordsDrug Product Market Exclusivity Biologics License Application Common Technical Document
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