Bioanalytical Laboratory Services

Our Bioanalytical Laboratory delivers high-throughput, high-sensitivity quantitative analysis to support Bioavailability/Bioequivalence (BA/BE) and Clinical pharmacokinetic (PK) studies. Operating in strict compliance with Good Laboratory Practice (GLP) and international regulatory guidances (US FDA, EMA, ICH M10), our state-of-the-art facility pairs advanced LC-MS/MS and HPLC platforms with validated automation to ensure robust data integrity from sample receipt to regulatory submission

We specialize in rapid method development and rigorous validation across complex biological matrices (plasma, serum, whole blood, urine etc). Equipped with Triple-Quadrupole mass spectrometers and automated sample prep workflows (liquid-liquid extraction, solid-phase extraction, and protein precipitation), our team routinely achieves sub-picogram sensitivity (LLOQ) and rapid sample turnaround. Every assay is thoroughly evaluated for selectivity, matrix effects, recovery, dilution integrity, and long-term storage stability

Operating under global regulatory compliant data architecture, we offer complete traceability, zero data contamination, and automated reporting. Whether analyzing high-volume generic drug samples or low-dose, modified-release formulations, we provide the scientific expertise, capacity, and audit-ready reporting required for seamless global dossier approvals