We offer bioanalytical services within the scope of determining the concentration of substances (unchanged drugs and their metabolites) in the biological material within the area of pharmacokinetics including services that form part of the necessary tests for registration of a given medicine – clinical research of early phases, bioavailability and bioequivalence studies. (Non-clinical / clinical research, Pharmacokinetics, Bioequivalence, Bioavailability).
The high quality of services is ensured by the introduced System of Good Laboratory Practice confirmed by acquiring the GLP certificate.
Within the scope of the provided services we offer:
- method development for determination of the drug in the obtained biological material,
- validation of the analytical method in accordance with the relevant EMA and FDA guidelines,
- performing determinations using the LC-MS/MS,
- preparing the analytical report in accordance with the international lab standards and the requirements of the customer,
- archiving study documentation and samples of biological material in monitored conditions in accordance with the current requirements.