We perform bioavailability (BA) and bioequivalence (BE) studies in accordance with EMA and international regulatory requirements. Our team supports comparative pharmacokinetic assessments for generic development, formulation changes, and lifecycle management. Studies are conducted under standardized conditions with precise sampling schedules and validated analytical workflows. Reliable execution and data integrity ensure regulatory-ready results suitable for submission and approval processes.
Ethics Committee approval for all studies
Medical supervision by experienced clinical staff
Clear participant information and informed consent
Conducted in compliance with ICH-GCP and EU regulations
