BioAnalysis has mastered the ability to provide our analytical services under strict current GMP conditions. Creating the necessary regulatory functions in just one year with our first GMP assays in 2022, we have since been audited more than 20 times by clients and prospective clients. We have yet to experience a critical observation. Remarkably, an unscheduled inspection from the FDA resulted in no major findings.

Our equipment is painstakingly qualified to enable GMP-compliant assays with AUC, HPLC, DLS, and LCMS technologies. BioAnalysis GMP policies and techniques are tested, thorough, and efficient.