Preparing for a Regulatory Inspection

This document provides a comprehensive overview of how to prepare for regulatory inspections conducted by agencies such as the EMA, MHRA, and FDA. It outlines essential steps for thorough preparation, emphasizes the importance of meticulous documentation, and highlights key differences in requirements and expectations among these agencies.

By understanding the core preparation steps and tailoring strategies to meet each agency's unique standards, this guide helps organizations ensure compliance, streamline inspection readiness, and navigate the regulatory landscape effectively.