Audits

Regulatory Sciences

FDA Inspection Readiness: Top Observations and How to Avoid a Form 483

For medical device manufacturers, FDA inspections are a critical component of regulatory oversight and quality assurance. Whether part of a routine surveillance program, pre-approval inspection, or...

Quality & Compliance

Staying Ahead: Why BIMO Inspection Readiness Audits Are Essential for Clinical and Biological Research Compliance

In the world of clinical and biological research programs, ensuring compliance with regulatory standards is not only essential for maintaining the integrity of studies but also for safeguarding the...