Quinta - Analytica

About Quinta - Analytica

Part of the CONSCIO GROUP, QUINTA is a GCP/GLP/GMP-certified, EMA & FDA-inspected European CRO offering in-house clinical testing, bioanalysis, CMC and R&D for small & large molecules, human & veterinary IMPs, generics & biosimilars. Our services include: 

1) Clinical Testing: 2 clinical units, capacity for 60+40 beds, BE/BA/PK studies.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 analyses: 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 analyses: GLP/GMP bioanalysis, CMC, characterizations of peptide & protein IMPs, biosimilars.

Quinta was founded in 1997, has been successfully inspected by FDA over 10 times.

Certifications
  • CZ
  • 2015
    On CPHI since
  • 3
    Certificates
  • 100 - 249
    Employees
Company types
Academic/Research
Biopharmaceutical company
Contract Research Organisation (CRO)
Contract Service
Distributor/Import Export
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Pharmaceutical company
Contact info
Meet us at

CPHI Frankfurt 2022

Messe Frankfurt, Germany
1-3 November 2022

Products from Quinta - Analytica (5)

  • Clinical testing

    Product Clinical testing

    Quinta - Analytica's in-house clinical Unit has been operating since 2007, with more than 600 BA/BE/PK studies completed and proprietary of over 270 validated bioanalytical methods. Equipped with a 60-bed on-site clinical unit in Prague and a soon to open 40-bed unit in Ostrava, we provide comprehensive servi...
  • Bioanalysis of small and large molecules

    Product Bioanalysis of small and large molecules

    Quinta - Analytica provides wide range of GCP/GLP bioanalytical services for preclinical and clinical studies with human and/or veterinary drug products up to Phase III. We offer development and validation of bioanalytical methods in different biological matrices; complete bioequivalence studies; pharmacokine...
  • Analytical research & development

    Product Analytical research & development

    Quinta - Analytica can help develop a wide range of analytical methods, impurities research, accelerated stability and degradation studies, trace analyses, extractables & leachables, formulation development of finished dosage forms and more. Using our analytical expertise and state-of-the-art equipment we...
  • Quality control and manufacturing process validation

    Product Quality control and manufacturing process validation

    Quality control and manufacturing process validation: Quinta - Analytica offers GMP-certified chemistry, manufacturing and controls assays (CMC) as well as analytical support during validation of manufacturing processes. Samples are analyzed by approved and validated methods for routine batch testing, stabili...
  • Biopharmaceutical analyses

    Product Biopharmaceutical analyses

    Quinta - Analytica is among the few CROs with both GLP and GMP services for large molecules, peptide & protein IMPs or biosimilars. Our services include method transfer and validation, bioanalysis and ADA determinations with ELISA, ECLA, UPLC or LC-FTMS, as well as GMP quality control, characterizations, ...

Quinta - Analytica Resources (3)