Bioanalytical Services

In-Vitro Biological Testing

Accurate and reliable bioanalytical data are critical to the success of drug, biologic, and device development programs. At MED Institute, we offer a full spectrum of bioanalytical services, including the development, validation, and execution of assays for quantification of drugs, biomarkers, and impurities in biological matrices. Our state-of-the-art laboratories and experienced scientific staff ensure that your studies meet regulatory requirements for GLP/GCP compliance. Whether you need support for pharmacokinetic, pharmacodynamic, or immunogenicity studies, we deliver high-quality data and regulatory-ready reports to support IND, NDA, BLA, or 510(k) submissions. Our extensive expertise includes:

• High-resolution mass spectrometry for precise and accurate analyte detection
• Capable of analyzing a diverse range of compounds, from small molecules to complex biologics.
• Ultrahigh-sensitivity assays with lower limits of quantification (LLOQ) in the sub-picogram per milliliter range