Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg.

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Bibliographic Details
:
TeilnehmendeR:
Year of Publication:2011
Language:English
Online Access:
Physical Description:ix, 284 p. :; ill.
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Table of Contents:
  • Controlling regulatory costs
  • Clear operation definitions of requirements
  • Pre-regulatory audits
  • Quality by design
  • Outsourcing
  • Electronic submissions
  • Emea/fda coordination
  • Managing FDA inspections
  • Risk assessment
  • Cases
  • Cost containment analysis
  • Managing regulation in times of chaos
  • International regulation
  • Cost contained regulatory compliance.