Quinta-Analytica

Quinta is a GCP/GLP/GMP-certified, EMA and FDA-inspected CRO offering in-house clinical testing, pharmaceutical analysis, CMC and R&D. Quinta specializes in clinical studies, bioanalytics, method development and quality control for both small and large molecules, biosimilars, human and veterinary IMPs as well as generics. We support pharmaceutical and biotechnology companies worldwide across the full drug development lifecycle from research and development through clinical trials to regulatory submission and market release. Our main service areas include: 1) Clinical Testing: With 2 in-house clinical units providing BE/BA/PK studies, with capacity for 60+36 beds. 2) Bioanalytical Testing: GLP/GCP solutions for BE/BA/PK preclinical & clinical studies, small molecules, biologics and biosimilars. PD studies upon request. 3) Pharmaceutical Quality Control: GMP quality control, batch testing, stabilities and HAPIs. 4) Biologics Quality Control: GLP/GMP bioanalysis, CMC, characterizations of peptide & protein IMPs, biosimilars, Cell-based assay. 5) Research & Development: Analytical R&D, impurities, extractables & leachables, degradation, trace studies. 6) Microbiology: GMP sterile & non-sterile testing, microbial/water analyses, endotoxins, antibiotics & vitamins. Quinta was founded and headquartered in Prague, Czech Republic in 1997 and has been successfully inspected by FDA more than 12 times. We are part of the Conscio group with headquarter in Munich (Germany) and laboratories in Czechia, Austria, Slovakia and Germany.