Bioanalytical Analysis
Your specialist for small molecule bioanalytical analysis.
State of the art (2 Hamilton systems and 6 mass spectrometric systems), SCC GLP certified, FDA audited laboratory for HPLC/MS/MS bioanalytical method development, validation, and quantification of drugs and metabolites in biological fluids/tissues. Data and reports meet FDA, EMA and ICH GLP standards, recently audited by FDA (2018, no 483’s) and Health Canada (2018).
- • Team of experienced scientists building selective, efficient, and robust methods ensuring quality pharmacokinetic data;
- • Resources are available immediately to put in place even the most demanding assays;
- • Independent Quality Assurance Unit for reliable facility compliance; our 1:2 ratio of quality service personnel to lab scientists demonstrates our commitment to quality and compliance of GLP/GCP regulations;
- • Additional services include Study Monitoring and Pharmacokinetics;
- • Our scientists develop and validate the most reliable new analytical methods, far exceeding the regulatory requirements on accuracy and precision;
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• From preclinical to clinical analysis, our methods have been successfully used in a wide array of therapeutic areas.
Contact us for news on our latest assays.