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, human and veterinary IMPs as well as generics. We provide unrivaled expertise to worldwide pharmaceutical and biotechnological clients across the entire pharma spectrum. Quinta is part of the Conscio group with headquarters in Munich, Germany, laboratories in Czechia, Austria, Slovakia, Germany and offices in the USA. 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) Research & Development: Analytical R&D, impurities, extractables & leachables, degradation, trace studies.
4) Pharmaceutical Quality Control: GMP quality control, batch testing, stabilities, HAPIs, inhalation, API sourcing.
5) Microbiology: GMP sterile & non-sterile testing, microbial/water analyses, endotoxins, antibiotics & vitamins.
6) Biopharmaceutical Quality Control: GLP/GMP bioanalysis, CMC, characterizations of peptide & protein IMPs, biosimilars.
Quinta was founded in 1997 and has been successfully inspected by FDA more than 10 times. Quinta is headquartered in Prague, Czech Republic.
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Obor
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Farmaceutická výroba
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Velikost společnosti
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200 - 500 zaměstnanců
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Ústředí
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Praha 10
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Typ
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Soukromá společnost
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Datum založení
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1997
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Speciality
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Clinical studies, Bioanalysis of small molecules, BA/BE studies and Phase 1, Pharmacokinetic and toxicokinetic studies, Analytical methods development, validation and transfer, Extractables and leachables, Impurities R&D, Nitrosamine screening and quantification, Formulation design, Bioanalysis of large molecules, GLP and GMP analyses of biopharmaceuticals, GMP quality control, release testing, stability studies, ICH and on-going stability testing, Analytics of Biosimilars, Characterizations of Biopharmaceuticals, Analytics of dry powder inhalers, Microbiological testing, In vitro release and permeation testing, Routine batch testing for release, API sourcing a Bacterial endotoxins
