The Clinical Pharmacology Unit of GVK Biosciences (GVK Bio) has received approvals from regulatory bodies such as US FDA, AFSAAPS, WHO and ANVISA. The approvals open up global markets to GVK BIO's clients in the US, Europe and Latin American countries in addition to the domestic sector.
Manni Kantipudi, president of GVK Bio stated, "The approvals validate GVK BIO's high quality systems and practices".
As a first step, GVK Bio has expanded and built a new state-of-the-art Bioanalytical facility in addition to the existing one to cater to the growing business demands. GVK Bio is also setting up its own Clinical Laboratory and aims for an early accreditation.
"GVK BIO aims to be a full service Clinical Research Organization offering services from BA/BE to phase I through phase IV Clinical Trials", said Mr. G V Sanjay Reddy, managing director, GVK Bio.
The Clinical Pharmacology Unit (CPU) located at Hyderabad, is one of the largest units in India for Bioavailability and Bioequivalence studies with state-of-the-art infrastructure to cater to global regulatory requirements. The SBU with 144 beds and a comprehensive volunteer database has the capability of undertaking studies for special dosage forms like injectables in addition to the conventional studies, which sets it apart from the competition. As of now, CPU has conducted around 300 studies of which more than 50 studies are for US FDA submission.