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Quinta Analytica

Pražská 18c/1486
102 00 Praha 10 - Hostivař
Czech Republic
main phone: +420 242 454 311(or 00)
Main fax: 420 242 454 384
Main email: quinta@quinta.cz
Homepage: http://www.quinta.cz/
Quinta Analytica

Quinta-Analytica is a contract research organization (CRO) located in the Czech Republic (member of EU), whose primary task is to supply pharmaceutical companies with analytical service. Quinta-Analytica specializes in the studies and analyses, which are required by the national regulatory authorities, before a pharmaceutical company can bring its new products to the market. Quinta-Analytica deals with complete analyses of drug substances, final dosage forms and metabolites according to the Good Manufacturing Practice (GMP) and/or the Good Laboratory Practice (GLP) guidelines. Quinta-Analytica holds a certification for all these activities.

Quinta-Analytica comprises four basic departments and an auxiliary packaging department. The Pharmaceutical Analyses Department provides analyses according to the GMP guidelines. The Research & Development Department performs research and development of methods in the field of pharmaceutical analyses. This department closely cooperates with The Pharmaceutical Analyses Department. The Bioanalytical Department carries out bioanalyses for pharmacokinetics/toxicokinetics and bioequivalences studies, including statistic evaluation according to the GLP guidelines. The Clinical Department performs clinical trials as a part of the bioequivalence studies according to the GCP guidelines. Dosage forms for research and development purpose are packaged by the Packaging Department. In September 2009, due to recent evolution on the field of biosimilars, a new department – Biopharmaceutical Analyses Department was established. It deals with the analyses of large molecules such as proteins applied in the biopharmaceuticals.

Quinta-Analytica has been regularly inspected by national (State Institute for Drug Control – SUKL) as well as international (European, South African and Brazilian) regulatory authorities. Quinta-Analytica passed a GLP audit by the U.S. Food and Drug Administration (FDA) in November 2005. GMP audits by the FDA were passed in 2006 and 2009.

Quinta–Analytica staff is comprised of 120 people, including management. There are 72 highly motivated research experts - graduated specialists with a Ph.D. (15), MSc. (53), M.D.(3), Bc. (1) experienced in analytical chemistry.

In late 2008 and early 2009, Quinta-Analytica began preparation for introducing LIMS to its laboratories. Also in 2009, due to the recent evolution in the field of biosimilars, Quinta-Analytica has initiated preparation for future activities in biopharmaceuticals.

Main domains

  • analytical methods development, validation and transfer for the evaluation of drug substances, intermediates and/or pharmaceutical products, including also chiral separation and impurity isolation and identification
  • quality control and release testing
  • stability studies on drug substances and/or dosage forms
  • packaging of dosage forms for research/development, stability studies and clinical trials
  • clinical trials, primarily the bioequivalence studies, including special population groups, e.g. postmenopausal women
  • pharmacokinetic/toxicokinetic studies in man and/or animals; primarily the bioequivalence studies