BIOANALYTICS

CLINFARM using bioanalysis Technologies based on UPLC-MS/MS.

GLP bioanalysis in CLINFARM are conducted in compliance with the Good Laboratory Practice Regulations (GLP).

CLINFARM develops news origin bioanalytic methods and conducts validation of them according with FDA (Guidance for Industry for Bioanalytical Method Validation) and current EU’s requirements in this field.

We conduct all investigations fast, quality, precision via our laboratory's equipments and scientists with many years’ pharmaceutical and bioanalytical study experience.

Our QA/QC manager conducts monitoring of all project’s aspects and verify the quality of the data.

In addition, CLINFARM provides full statistical analysis for pharmacokinetic parameters using validated software such as WinNonLin on base produced data of preclinical or clinical study of investigated medicines

We also provide fully integrated BA/PK reports appending the bioanalytical results to the PK/TK interpretation.

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