Quinta - Analytica

About Quinta - Analytica

Founded in 1997, Quinta-Analytica is an well recognized one-stop-shop company offering five main pillars of the business for worldwide pharmaceutical companies:

1) Pharmaceutical Analyses - analysis and testing, quality control, batch release, stability studies and more

2) Analytical R&D - research & development of the analytical methods

3) Clinical Testing - in-house operating Clinical Unit provides with BE/BA/PK studies

4) Bioanalytical Testing - Complete integrated solution for GLP/GCP compliant BE studies and preclinical studies 

5) Biopharmaceutical analyses - complete analytical services for large molecules 

Quinta-Analytica is inspected by FDA and besides of above we can offer expertise in analytics of inhalers, peptides and proteins (large molecule analyses generally including biosimilars) as well as consultancy in Regulatory and Clinical Strategy. 

Quinta-Analytica operates in full compliance with GCP/GLP/GMP and also FDA standards. 

Due to joint-venture laboratory located in Russia we can support our business partners also in terms of their needs of pre-clinical and clinical studies on Russian market.   

Certifications
  • CZ
  • 2015
    On CPhI since
  • 2
    Certificates
  • 100 - 249
    Employees
Contract Service
Contact info

Products from Quinta - Analytica

  • Analyses of highly potent substances

    Product Analyses of highly potent substances

    Quinta - Analytica provides wide range of pharmaceutical analyses services which includes analyses of highly potent substances. It uses highly potent substance laboratory (hpsl) which consists of a set of analytical laboratories within a hygienic loop, equipped with dedicated equipment and specially trained personnel and are able to run such highly potent drug project separately from the other projects, with a special attention to the safety of personnel. The highly potent drug projects currently represent a significant part of the company portfolio. Contact us for more information.
  • Analyses of inhalation products

    Product Analyses of inhalation products

    Quinta - Analytica provides wide range of pharmaceutical analyses services which includes analyses of inhalation products. As new unique it's speciality, a laboratory for testing dry powder inhalation products (in inhalation devices) is now in full operation. This laboratory has all necessary conditions (controlled temperature and humidity) and equipment for testing. Contact us for more information.
  • Analytical support of formulation development

    Product Analytical support of formulation development

    Quinta - Analytica provides wide range of pharmaceutical analyses services which includes analytical support of formulation development. During formulation development of the finished dosage form, many trial batches are produced and must be analyzed on various parameters like assay of the active substance, purity, water content, hardness, etc. The fast and reliable results from the analytical laboratory are crucial for the continuation of the formulation development in the right direction. Contact us for more information.
  • Analytical support of manufacturing process validation

    Product Analytical support of manufacturing process validation

    Quinta - Analytica provides wide range of pharmaceutical analyses services which includes analytical support of manufacturing process validation. Manufacturing validation of the finished dosage form is the one of the most important processes in the GMP production. Manufacturing process has to be validated under GMP. Therefore, many samples are collected during that period and have to be analyzed by approved and validated methods. Manufacturer's analytical laboratory has sometimes insufficient capacity, therefore, our laboratory can easily take over its duties. Contact us for more information.
  • Bioanalyses

    Product Bioanalyses

    Quinta - Analytica provides wide range of clinical trials and bioanalyses services which includes bioanalyses. The extent of provided services are: development and validation of bioanalytical methods in different biological matrices; complete bioequivalence study in human and/or animals; pharmacokinetic/toxicokinetic study in human and/or animals; analysis of drugs and metabolites in different biological matrices; identification of metabolite chemical structures. Contact us for more information.
  • Bioequivalence / GxP in Russia

    Product Bioequivalence / GxP in Russia

    Quinta - Analytica provides wide range of clinical trials and bioanalyses services which includes bioequivalence / GxP in russia. It offers a comprehensive set of services to the companies targeting russian generic market. Whether it is looking for assistance with regulatory submissions in russia, preclinical studies in generics or require a full range of bioavailability/bioequivalence. It offers development hypothesis and milestone evaluation in BA/BE area; type of study (e.g. 2 way, fully replicated, two stage etc.) in line with current russian guidelines; calculation of sample size, variability estimation, blood sampling optimization, study population; selection of clinical site for ba/be study in russia development support, etc. Contact us for more information.
  • Clinical Trails II.-IV. Phase

    Product Clinical Trails II.-IV. Phase

    Quinta - Analytica provides wide range of clinical trials and bioanalyses services which includes clinical trails II.-IV phase. It can offer the following organization of trials as required by the sponsor. For example: study protocol writing and study design; subject size determination and randomization; case report forms (crfs) design; informed consent forms writing; independent ethics committee submissions. Contact us for more information.
  • Degradation studies

    Product Degradation studies

    Quinta - Analytica provides wide range of analytical research and development services which includes degradation studies. It is a tool to check and evaluate methods which have been developed to be stability-indicating. The principle of FDS lies in stressing a drug under physical and chemical conditions, which may force the sample to degrade rapidly thereby producing yet unknown impurities. The idea is to simulate the profile of impurities which may develop during a long-term storage of the product. Contact us for more information.
  • Development of analytical methods

    Product Development of analytical methods

    Quinta - Analytica provides wide range of analytical research and development services which includes development of analytical methods. Development and testing of new analytical methods represents the primary activity. Most frequently when asked for a new method development for the following reasons: it is necessary to monitor reaction conversions and impurity levels in intermediates during the development of a new synthetic route of an active pharmaceutical ingredient (api); assay or purity method described in a corresponding pharmacopoeia is obsolete or does not comply with customer's requirements; the analytical method for purity or assay of api in a new drug product is simply not available; a final drug product represents a novel combination of API's; no analytical method exists for determination of the particular auxiliary chemical of impurity. Contact us for more information.
  • Development of LC/MS methods for the trace levels

    Product Development of LC/MS methods for the trace levels

    Quinta - Analytica provides wide range of analytical research and development services which includes development of lc/ms methods for the trace levels. The skill in the development of analytical methods for determination of trace amounts of tracked impurities. For customers it usually develops methods for assessment of toxic impurities at levels much below those demanded by corresponding regulatory authorities. Often it deals with systems where the target components are susceptible to decomposition or can react easily with the active ingredient or sample matrix. Despite these challenges, it continues to succeed with the development of such methods. Contact us for more information.
  • GMP Packaging/labelling for stability studies and clinical trials

    Product GMP Packaging/labelling for stability studies and clinical trials

    Quinta - Analytica provides wide range of other services services which includes gmp packaging/labelling for stability studies and clinical trials. The department of packaging is a separate unit within dealing with primary and secondary packaging in small scale of the solid dosage forms into blisters/strips or containers for research purposes, for clinical trials, and stability studies. It has at its disposal a GMP laboratory equipped for packaging and also holds valid manufacturing authorizations pursuant to the law. Contact us for more information.
  • Heterogeneity

    Product Heterogeneity

    Quinta - Analytica provides wide range of biopharmaceutical analyses services which includes heterogeneity. Due to the feasible chemical modification of amino acids, proteins undergo various kinds of post-translational modifications (ptms), which make them inherently heterogenous. It cannot usually be predicted from the gene sequence and since they have significant impact on proper function of a specific protein, they need to be thoroughly evaluated. List of currently available analytical techniques: LC-MS/MS; capillary electrophoresis; gel electrophoresis. Contact us for more information.

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