Small Molecule Services
  • Method Development and/or Optimization to improve assay performance
  • Non-GLP Method Qualification or Full Validation to GLP standards, depending on study needs
  • Method Transfer for sponsor-supplied methods
  • High-throughput analysis for clinical and preclinical studies¬† according to GLP and GCP regulations and guidelines
  • Customized, bar-coded Clinical PK¬†collection kits for US or global studies
  • Biorepository services with reliable sample tracking
Expertise
  • Bioanalysis of chiral compounds, endogenous compounds and biomarkers
  • Specialists in a variety of biological fluids and hard, soft and complex tissues, including:
    • Arterial: Pig
    • Bladder: Dog, Rat
    • Brain: Monkey, Rat
    • Emesis: Dog
    • Feces: Dog, Human, Monkey, Rat
    • Heart, Liver, Lung, Kidney: Dog, Monkey, Pig, Rat
    • Nail: Human
    • Tumor: Human
    • Skin: Cat, Pig
    • Sputum: Human
Assays
Instrumentation
  • 15 AB Sciex LC-MS/MS systems (5500 QTrap, 5000, 4000, 3000)
  • Precellys 24 homogenizer
Quality Systems
  • SOP-driven validations based on current FDA and industry guidance
    • Incurred sample analysis and outlier analysis SOP
    • Client’s customized validation protocols
  • FDA audited and fully compliant

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