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

By: Material type: TextTextPublication details: Hoboken, N.J. : John Wiley & Sons, ©2011.Description: 1 online resource (284 pages)Content type:
  • text
Media type:
  • computer
Carrier type:
  • online resource
ISBN:
  • 9780470933503
  • 047093350X
  • 9780470933510
  • 0470933518
  • 9781118002278
  • 111800227X
  • 1283025604
  • 9781283025607
Subject(s): Genre/Form: Additional physical formats: Print version:: Cost-contained regulatory compliance.DDC classification:
  • 615.1068/1 22
LOC classification:
  • HD9994.U52 W45 2011eb
NLM classification:
  • QV 736
Online resources:
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.
Summary: This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
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Includes bibliographical references (pages 273-277) and index.

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.

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.

Print version record.

Biotechnology & Bioinformatics