Regulatory Compliance

Proven strategies and case studies on how to contain regulatory costs in the healthcare industries This book outlines a comprehensive strategy for controlling the cost of regulatory compliance in the pharmaceutical and medical industries. It provides professionals in the field with the tools they need to cut costs in submissions, compliance, and regulatory affairs while maintaining the quality and safety of their products. Drawing on decades of regulatory experience, the author identifies eight field-tested strategies designed to eliminate redundancy, waste, uncertainty, inertia about regulatory guidelines, and other areas that add cost without adding value. He uses real-world case studies to illustrate the techniques, offering analysis and advice on implementation in different circumstances and industries. Copies of official documents from the FDA and other agencies are also included. Readers will find no-nonsense, practical tips, and guidelines on how to: Clarify requirements to avoid overly zealous or "just to be safe" compliance that exceeds regulatory expectations Reduce FDA response and review time through independent audits and the adoption of electronic submissions Devise a simultaneous submission strategy to deal with FDA/EMA overlap Automate the quality control process through the use of Quality by Design (QbD) systems Use outsourcing in a constructive way to reduce overhead and tap outside expertise Take a proactive approach to FDA inspections and investigations and utilize risk-assessment management techniques