Bioavailability & Bioequivalance (BA/BE) Study

Our Clinical Operations team delivers end-to-end execution for Bioavailability and Bioequivalence (BA/BE) studies, supporting global regulatory submissions across the US FDA, EMA, MHRA, ANVISA, CDSCO and PPB. Operating from a purpose built Clinical Pharmacology Unit (CPU) with dedicated confinement capacity, 24/7 medical oversight, and biometric verified volunteer screening to prevent cross-participation, we ensure rapid study start up, accelerated enrolment, and total compliance with ICH-GCP (E6 R2) standards

Every phase is tightly controlled, covering fasting, fed, replicate or modified-release study designs. Our workflows feature direct observation dosing, standardized nutritional meal administration, and tracked serial pharmacokinetic (PK) blood collection. Immediate on-site refrigerated centrifugation and validated -20°C/-80°C cryostorage safeguard biological sample integrity prior to bioanalytical handover

By combining stringent quality control, global regulatory compliant data management, and continuous subject safety monitoring, we minimize pre-analytical variability and compress clinical timelines