Most activities of the Bioanalytical department, which collaborates with the Clinical department of the company, are focused on conducting complete bioequivalence studies (including clinical, analytical, pharmacokinetic and statistical part) as well as the analyses of diagnostic biomarkers.
The Bioanalytical department comprises a team of experienced analysts and laboratory technicians. The laboratories are equipped with nine modern LC/MS/MS devices with triple quadrupoles, six of which being additionally equipped with a 2-channel HPLC system. The capacity of the Bioanalytical department is up to 3,750 analyses of biological samples per day (including calibration and QC samples and depending on the complexity of the analyses).
Bioanalytical methods are developed and validated in accordance with GLP rules and ICH/FDA and EMEA guidelines. So far, over 300 methods have been developed and validated in the company. Please see below for a full list of our bioanalytical methods, and if you don't find what you're looking for please contact us.
In the area of pre-clinical evaluation of active ingredients in animals, the Bioanalytical department cooperates with partners in the Czech Republic as well as in the world and conducts its own toxicological and pharmacokinetic studies.
During these activities, Quinta provides complete analytical support comprising inspections of the quality of the application forms, analyses of the studied active ingredients and metabolites in the collected biological samples. Quinta also performs the subsequent toxicokinetic and pharmacokinetic evaluations.
Within clinical trials in different phases, the Bioanalytical department cooperates with the Clinical department of Quinta as well as with external clinics in the world that conduct their own PK/PD and BA/BE studies.
The Bioanalytical department provides a complete analytical support from the preparation of protocols, through the development and validation of bioanalytical methods, preparation of the sampling manuals for clinical workplaces, analyses of the studied active ingredients and/or metabolites in the collected biological samples to the pharmacokinetic and statistical evaluation of the studies.
In addition to its own Clinical department in the company, the Bioanalytical department cooperates with many clinics involved in Phase I clinical trials. Highly trained and experienced employees also take part in determining the structure of metabolites and their isolation from biological matrices.
We perform calculations of pharmacokinetic parameters and statistical evaluation of the results of studies results using specialized software:
Broad portfolio of active ingredients from reliable, established manufacturers, guaranteed by our expertise.
Based on isotopically labeled standards, our customizable in-house detection methods are available immediately.
Expertise in helping to compile dossiers and drug registration processes.
Oversight of participant health and correctness of treatments during clinical studies.
Monitoring of daily routine to detect unrecognized adverse events, plus assess and ensure drug safety.
Thorough dossier M3 data audit to ensure consistency and compliance with regulatory requirements.
Via our partnering CRO in Russia we can help you to perform clinical trials to apply for Russian MA.
As an EU based company we are well-placed to help create & develop your IMPD.
It's not an exhaustive list so if you don't see what you need, contact us.
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