Clinical research

Jubilant Pharmaceuticals frequently coordinates execution of bio-equivalence studies for EU submissions.

BE studies are performed as per ICH-GCP guidelines at our in-house CRO Jubilant Clinsys, a state-of-the-art 62-bed facility in India which was EU inspected by the Dutch and German authorities.

This facility has its own bioanalytical, pharmacokinetic and clinical Lab, statistical and quality assurance units all under one roof.

When coordinating BE studies, we ensure that all operations from protocol development up to final clinical study report are taken care of, while minimizing the input and responsibilities at the customer’s side.

Our capabilities are in performing Bioequivalence/Bioavailability and Pharmacokinetic Services:

• Single or multiple dose studies
• New dosage/delivery systems
• Food effects Studies
• Bioanalytical method development and validation