Preclinical & Clinical Development Development Services
Our Regulatory Compliant Laboratory (RCL) is a CRO leader in the development, validation and application of ligand binding assays enabling development of biopharmaceuticals and translational biomarker applications. The RCL designs, develops, optimizes and validates analytical techniques for pharmacokinetic assessments of biotherapeutics, determination of novel biomarkers, and detection of anti-drug antibodies (immunogenicity testing). These activities comply with regulatory expectations (CLIA, GLP, OECD), including computer validation (21 CFR Part 11) and oversight by our Quality Assurance unit.
