Bioanalysis
Our GLP-compliant bioanalytical services provide accurate PK, TK, and PD data through optimized workflows and sensitive biomarker assays for regulatory success.
Bioanalysis
Bioanalysis (PK/TK/PD) – GLP Compliant
Bioanalysis is essential for understanding drug absorption, distribution, metabolism, and effect. GLP compliance guarantees data integrity and reliability for both preclinical and clinical programs.
How we can help
With extensive experience in bioanalytical testing, we provide GLP-compliant bioanalytical services for pharmacokinetics (PK), toxicokinetics (TK), and pharmacodynamics (PD) studies. Our ligand-binding and cell‑based technology platforms ensure accurate, reproducible data to support your drug development programs, regulatory submissions and clinical success.
Choose from our broad range of products and services including:
- Ligand–binding assays
- Ready-to-use iLite® functional bioassays
- CRO Bioanalytical services
- GLP-certified LC-MS/MS services through our partner Lablytica
From assay development and qualification to routine sample analysis, we provide reliable, mechanism-of-action reflective data that meets regulatory requirements and accelerates decision-making.
Our Bioanalysis Solutions
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CRO SERVICES
We quantify drug concentrations over time to characterize absorption, distribution, metabolism, and excretion. Validated methods, calibration strategies, and rigorous QC ensure reproducible exposure profiles for decision making and submissions.
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CRO SERVICES
TK analysis links exposure to toxicology findings to inform safety margins and dose selection. Workflows are GLP compliant with clear acceptance criteria and structured reporting for regulatory packages.
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CRO SERVICES
PD assays measure biological effect and target engagement to connect exposure with response. We combine functional readouts and biomarkers to create coherent PK‑PD narratives for your program.
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CRO SERVICES
End‑to‑end GLP services include method development, validation, sample management, and data review. Electronic records, audit trails, and QA oversight support data integrity and inspection readiness.
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COMPLEMENT ASSAYS
WIESLAB® complement kits integrate into bioanalysis to monitor immune activation signals that affect exposure and safety. Assay‑ready formats and clear SOPs facilitate multi‑site deployment and study comparability.
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CELL-BASED BIOASSAYS
iLite assays provide mechanism-of-action‑reflective PD and biomarker measurements that pair naturally with PK and TK data. Delivered as assay-ready cells with standardized protocols, they ensure rapid startup and reproducible performance across studies and timepoints, while reducing reagent requirements and minimizing cell culture time.
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CRO SERVICES
Through our partner, Lablytica, our clients have access to GLP-certified LC-MS/MS services for quantitative analysis of small and large molecules. Services include method development, validation, and sample analysis for PK/PD studies and therapeutic drug monitoring, fully aligned with FDA, EMA, and ICH M10 guidelines.
Contact our team of experts
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