Cost-contained regulatory compliance
Subtitle: for the pharmaceutical, biologics, and medical device industries
By: by Sandy Weinberg
Publisher: John Wiley & Sons
Published: 2011
Place of publication: Hoboken, N.J
Language: eng
ISBN-13: 9780470552353
Table of contents: title: Controlling regulatory costs; title: Clear operation definitions of requirements; title: Pre-regulatory audits; title: Quality by design; title: Outsourcing; title: Electronic submissions; title: Emea/fda coordination; title: Managing FDA inspections; title: Risk assessment; title: Cases; title: Cost containment analysis; title: Managing regulation in times of chaos; title: International regulation; title: Cost contained regulatory compliance.