QUINTA-ANALYTICA

Founded in 1997, Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Their main domains are pharmacokinetics and BA/BE clinical studies (EMA, FDA, CAN, Russia), bioanalytics, drug analysis including method development and transfer (GMP/GLP analytics of drug substances, final dosage forms and metabolites), batch QC release, stability studies, analytics in inhalation antiasthmatics, peptides and proteins. Also the... y provide consultancy in Regulatory Clinical Strategy. They are based in Prague, Czech Republic. They have 3 European Qualified Persons. Quinta holds GMP, GLP and GCP certificates. Quinta-Analytica consists of six divisions: Pharmaceutical Analysis Division carries out GMP analyses of final products and API. Phasma Analysis labs use LIMS. R&D Division develops methods for pharmaceutical analyses. Bioanalytical Division analyzes samples from pharmacokinetics/toxicokinetics and bioequivalences studies, including pharmacology and biostatistics. It works in line with GLP and GCP guidelines. They have 2 in-house Clinical Units at Quinta's facility in Prague and several partner Units in Russia and Georgia. The Units are used for BA/BE studies according to the GCP guidelines. Department of Biopharmaceuticals specializes in analysis of large molecules (proteins, peptides). Dosage forms for clinical studies are packaged by the Packaging Department. Quinta-Analytica is regularly inspected by European agencies represented in Czech Republic by State Institute for Drug Control (SUKL). Quinta has successfully passed through several FDA audits: GMP 2006, 2009, 2013, GLP 2005, 2010, 2014 and GCP 2015. Quinta has GMP, GLP, GCP certications for human medicines, and GMP certification for veterinary medicines.More