QPS China – Suzhou
- QPS China in Suzhou is a GLP-compliant CRO, specializing in bioanalysis supporting preclinical and clinical drug development research.
- Established in 2018 and located at Suzhou Industrial Park, the facility encompasses 5,000+ square feet.
- Bioanalysis (small molecules, peptides, and oligonucleotides) in compliance with China FDA, Taiwan FDA, US FDA, and EMA registration.
- Biosafety level 2 (BSL 2) facility to handle bioanalysis of BSL 2 agents, such as human immunodeficiency virus (HIV), hepatitis virus A, B, C, D, and E (HAV, HBV, HCV, HDV, HEV), influenza virus, coronavirus (SARS CoV, MERS CoV, SARS CoV 2),…
- Sciex mass spectrometry platform with Nexera UPLC front-ends: Triple Quad 4000, TripleToF 6600.
- Watson LIMS for data management.
- REES for automated temperature and moisture monitoring.
- Head of the facility has a Ph.D. in mass spectrometry from the University of Michigan and worked 20+ years in QPS DE as Director of Bioanalysis before taking up the position in QPS Suzhou.
- Principal Investigators (PIs) have multiple years of relevant experience.
Quality Management System
- SOP administration.
- Employee qualifications.
- Equipment program.
- Validation team (users, IT, QA, and management), validation plan, IQ/OQ/PQ.
- Quality assurance audits.