Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries
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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acceptable analysis application approach appropriate approval audit auditor automated biologics cGMPs clinical Common Technical Document condoms consultant containment control articles Cost-Contained Regulatory Compliance cost-containment strategy CP-Bio credible defined design space documents Drug Administration drug discovery eCTD backbone files effective electronic submissions employees European Medicines Agency Evaluation expense experience expertise facility FDA and EMEA FDA investigators FDA visit FDA’s folder Food and Drug guidance guidelines identified implementation in-house inspection issues laboratory manufacturing Manufacturing Practices Medical Device Industries ment module monitoring operational definition organization outsourcing pharmaceutical potential problems Process Analytical Technology protocol QA/QC quality assurance Quality by Design quality control regulation regulatory agencies regulatory costs requirements responsibility result risk assessment safety sample self-regulation significant SOPs specific Standard Operating Procedures testing tion Trace Matrix validation Wiley & Sons Yes No N/A