Following cGCP and cGLP standards, our partners are experts in conducting BA and BE studies.

• BA/BE studies for EU generics and US ANDA applications
• Small and large molecule BA/BE studies
• In-vitro / in-vivo correlation (IVIVC)
• Comparative BA/BE study
• Study fasting and fed conditions on BA/BE
• BA/BE studies for immediate release (IR) and modified / Controlled release (MR/CR) formulations
• BA/BE studies for different routes of administration
• Setting up study design
• Preparation of study protocols
• Independent Ethics Committee – Review and Management
• Preparation of Case Report Forms (CRFs)