FARMOVS (PTY) LTD

Bio Analysis

Bio 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 580 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.