Phases

BioAgilytix is a key partner in drug discovery, providing unrivaled expertise and technologies in bioanalysis for our partners. Our proven capabilities in assay development, biomarker analysis, and pharmacokinetic assessments allow sponsors to efficiently identify, validate, and optimize lead candidates for successful drug development programs.

BioAgilytix offers comprehensive preclinical support through our pharmacokinetics (PK) and drug metabolism, immunogenicity, biomarker, and CMC bioanalytical services. We work scientist to scientist, collaborating with our clients to deliver integrated bioanalytical solutions for their toughest preclinical drug development needs.

The clinical stage is a critical part of the drug development process, where potential therapies are tested on human subjects to evaluate safety, efficacy, and dosage. We are the partner trusted most by leading biopharma organizations for our unrivaled program experience and deep scientific expertise in both large and small molecule clinical development.

Proper CMC processes enable quality control by identifying and quantifying manufactured materials, optimizing manufacturing processes, and conducting stability studies on drug substance, drug product, or other constituents of the formulated therapeutic. Bioanalytical methods are employed to measure drug concentrations, determine pharmacokinetic, physical, and chemical properties, and to establish appropriate dosage regimens.