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Bioanalytical services


Fully complying with the GLP regulations, our authorized bioanalytical laboratory provides selective and sensitive analytical method for active substances and metabolites quantification from biological fluids.

We can provide documented and validated methods for bio-fluids dosing of the active substances listed.

Upon request, we have the ability to promptly develop LC-MS/MS, LC-UV and LC-Fluorescence methods for other active substances and metabolites.

Bioanalytical capabilities:

  • Bioanalitycal method development and validation;
  • Adaptation and Re-validation of the sponsor method, if required;
  • Estimation of active substance/metabolite concentration in different biological matrices;
  • Dissolution profiles and dissolution tests as substitute for bioequivalence studies (biowaiver type studies).
Equipment:
  • LC/MS/MS;
  • HPLC systems, fully equipped with different types of detection (UV, fluorescence);
  • Refrigerated centrifuges;
  • Automated Dispensers/ dilutors;
  • Nitrogen Evaporators;
  • UV/VIS photometer;
  • Dissolution test device;
  • PH meters;
  • Device for providing chromatographic water;
  • Freezers with permanently controlled temperature and phone alarm.
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