GLP Bioanalysis:
Our facility and information technology system are meticulously designed and well maintained for LC/MS-based GLP bioanalysis studies. The critical and non-critical equipment such as HPLC, mass spectrometer, sample storage systems, balances and pipettes are qualified and calibrated. Our staff are fully trained to work in compliance with the current FDA and OECD guideline and our comprehensive standard operation procedures. We provide comprehensive GLP bioanalytical method validation following current regulatory guidance in evaluating specificity, linearity, accuracy, precision, stability, recovery, matrix effect, carryover, and reproducibility. Our dedicated Quality Assurance ensures uncompromised quality systems including SOPs, protocols, methods, practices, records, reports, trainings, and facilities.