Analytical and Bioanalytical Services
We offer comprehensive analytical and bioanalytical testing to support toxicokinetic, pharmacokinetic, and drug development studies for small and large molecules.
Analytical and Bioanalytical Services
• PK/TK Analysis (Small and Large Molecules): Specialized expertise in analyzing drug concentrations in biological samples for both small and large molecular compounds.
• Method Development and Validation: Creating and validating robust analytical methods for measuring substances in various biological matrices (blood, plasma, urine, feces, bile, cerebrospinal fluid, and tissues like brain, lung, heart, liver, kidney, spleen, skeletal muscle, ocular tissues).
• Formulation Analysis: Detailed chemical analysis of drug formulations to meet sponsor-specific requirements.
• Chemical Characterization: Comprehensive analysis of medical devices, including leachable and extractable analysis.
• Concentration Verification and Stability Studies: Ensuring consistent drug concentrations and evaluating the stability of compounds over time.
• Pre-formulation & Compatibility Studies: Providing support for early-stage drug development, including studies on forced degradation and compatibility to ensure product stability.
• Product Lifecycle Support: Assistance throughout the entire product development lifecycle, from early pre-formulation stages to commercialization and beyond.