We help pharmaceutical companies prepare for FDA inspections with tailored audit readiness services. We identify gaps, train teams, and simulate inspection scenarios to ensure GMP compliance and successful FDA outcomes for drug manufacturing, packaging, and documentation processes.
IntroductionAn FDA Inspection Readiness Audit is a proactive evaluation of your facility, documentation, and quality systems—designed to uncover potential issues before regulators do. It simulates a real FDA inspection and...
IntroductionAn unexpected FDA inspection can either validate your compliance efforts—or expose costly gaps. Being prepared is not just about documentation; it’s about building a culture of continuous compliance across your...
The FDA inspection readiness audit is a critical process for organizations in regulated industries, such as pharmaceuticals, medical devices, and food production. It ensures compliance with FDA regulations, identifies gaps...
