About us

Founded in 1997, Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Our 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 we provide consultancy in Regulatory Clinical Strategy. We are based in Prague, Czech Republic. We 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. We 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.

Quinta–Analytica employs > 120 people including 15 PhD, 53 MSc and 5 MD

Summary:

• Clinical studies with pharmacokinetics endpoints (EMA, FDA, CAN, Russia, Ukraine)
• Pharmacodynamics studies
• Bioanalytics – own in-house lab - human/animal - 10 LC/MSMS
• Drug analysis – own in-house labs, including method development and transfer
• EU Qualified Person services, Batch QC release, IMPD QC release in EU
• Stability studies
• Inhalation antiasthmatics - pharmacopeial testing of powder inhalers
• Own in-house clinical unit PK/BA/BE/PD
• Partner clinical units in Russia and Georgia
• Regulatory & clinical strategy consulting in EU and Russia
• Consulting in registration of biosimilars in Russia/CIS
• Local clinical studies in Russia including BE/BA
• Audited by FDA and EU DRA | Certified GMP/GLP/GCP