Quality System Overhaul
When a series of test failures, warning letters, 483s, or audit findings point to serious gaps, it’s not enough to patch the issues. You need a durable, inspection-ready quality system that prevents future failures and restores regulator confidence.
Whether your system has slowly unraveled over time—or cracked under FDA or state agency pressure—we help you rebuild the structure that supports safe, compliant drug production.
What’s Included
Investigate citations or operational failures
Deliver a clear root cause analysis report
Develop a targeted CAPA plan
Redesign weak procedures, roles, and workflows to prevent recurrence