Laws and Regulations: The Discipline of Regulatory Affairs

  • Elaine S. Waller
  • Nancy L. Kercher

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.


Drug Product Market Exclusivity Biologics License Application Common Technical Document 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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  1. 1.
    Matthieu M (ed). New Drug Development: A Regulatory Overview, 6th Ed., Parexel International Corp., Waltham, MA, 2002Google Scholar
  2. 2.
    Matthieu M (ed). Biologics Development: A Regulatory Overview, 3rd Ed., Parexel International Corp., Waltham, MA, 2004Google Scholar
  3. 3.
    Available at

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Elaine S. Waller
    • 1
  • Nancy L. Kercher
    • 2
  1. 1.Regulatory Affairs & Quality AssuranceSonus PharmaceuticalsWA
  2. 2.Strategic Biotechnology ConsultingWA

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