About

About QUINTA-ANALYTICA s.r.o. Quinta-Analytica, as a member of Conscio Group, is a GCP/GLP/GMP-certified, EMA and FDA-inspected CRDO specializing in services for both small and large molecules. These services include formulation development, IMP manufacturing, method development and QC, clinical (PK) studies and bioanalytics for both human and veterinary drugs. 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 preclinical & clinical studies, small & large molecules, BE/BA/PK. 3) Biologics Quality Control: GLP/GMP bioanalysis, CMC, characterizations of peptide & protein IMPs, cell-based assays, biosimilars. 4) Pharmaceutical Quality Control: GMP quality control, batch testing, stabilities, HAPIs, inhalation, API sourcing. 5) Research & Development: Analytical R&D, impurities, extractables & leachables, degradation, trace studies. 6) Formulation development and IMP manufacturing: Innovative approaches in solid & semi-solid and special dosage forms, bioavailability improvement, up to OEB 5 class and narcotic molecules. Quinta-Analytica, as a member of Conscio Group, is a GCP/GLP/GMP-certified, EMA and FDA-inspected CRDO specializing in services for both small and large molecules. These services include formulation development, IMP manufacturing, method development and QC, clinical (PK) studies and bioanalytics for both human and veterinary drugs. 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 preclinical & clinical studies, small & large molecules, BE/BA/PK. 3) Biologics Quality Control: GLP/GMP bioanalysis, CMC, characterizations of peptide & protein IMPs, cell-based assays, biosimilars. 4) Pharmaceutical Quality Control: GMP quality control, batch testing, stabilities, HAPIs, inhalation, API sourcing. 5) Research & Development: Analytical R&D, impurities, extractables & leachables, degradation, trace studies. 6) Formulation development and IMP manufacturing: Innovative approaches in solid & semi-solid and special dosage forms, bioavailability improvement, up to OEB 5 class and narcotic molecules.