FARMOVS Bioanalytical Services Division

Our facilities are geared for world-class drug development

Extensive access to validated
bioanalytical methods

Bioanalysis is the discipline that allows quantitative determination of chemical entities and biomarkers in biological matrices.
FARMOVS offers the highest quality bioanalytical services for qualitative and quantitative drug, metabolite, and biomarker analysis in a variety of matrices. With our advanced technology and backed by 30 years of bioanalytical experience, we have developed an extensive database with more than 550 internally developed and validated analytical methods that adhere to ICH and FDA guidelines. Our methods have been used in more than 3,000 pre-clinical and clinical trials. New analytical methods are developed continuously for our clients. The laboratory routinely performs safety testing for clinical chemistry and hematology analysis.

Our bioanalytical division offers a wide range of services:

  • PK analysis

  • 15 LC-MS/MS instruments (11 x API4000 and 4 x API5500)

  • Development and validation of new bioanalytical assays

  • More than 550 validated methods used in over 3,000 clinical and pre-clinical trials to date

  • Clinical laboratory

  • Routine safety testing (serology, hematology and clinical chemistry)

  • Immunochemistry laboratory PK/PD analysis of macromolecules using RIA, ELISA, ECL

  • Several methods have been developed for proprietary drugs and these are not listed in this document due to confidentiality

  • Our validation procedures and SOP’s are in compliance with the United States of America (FDA) and European (EMEA) guidelines

  • The laboratories are GLP certified and were successfully inspected by the FDA, MHRA, WHO and EMA

  • Analysis of 120,000 samples per year – more than 50% comes from contract research organisations outside the South African borders.

VALIDATED ASSAY METHOD

For more detail on the Validated Assay Method, download a full brochure:

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