We handle all types of bioavailability (BA)/ bioequivalence (BE) studies in healthy human male and female volunteers in accordance with International Conference on Harmonization (ICH)-Good Clinical Practice (GCP) guidelines. Two clinics of 40 beds each are spread in 14,000 square feet area. Both the clinics seamlessly combine into a single 80 bed clinic for larger studies. With an extremely large female volunteer database of about 500 we currently conduct a large number of female studies. Our large female volunteer database with our unique facility design enables us to conduct mixed gender studies complying with global ethical standards. Our volunteer registration software is equipped with biometrics and is 21 CFR Part 11 compliant. “Our on-site qualified pharmacists, formulation scientists and supporting Quality Assurance (QA) staff from our product development with the know-how, cGMP materials & qualified equipment are uniquely qualified in compounding your tough formulations right before the clinical study” We conduct the following studies for our partners across the globe: :
Our capabilities includes:
Accreditations: Our clinical laboratory was accredited by NABL (National Accreditation Board for Testing and Calibration Laboratories) Compliments our boutique of clinical services Our dedicated pharmacokinetics & biostatistics team provides statistical support using Win-Nonlin and Statistical Analysis System (SAS)with focus on your timelines and quality control. Capabilities include:
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