By IANS
Hyderabad : World’s major healthcare product regulatory authorities have accorded their approvals to the Clinical Pharmacology Unit (CPU) of GVK Biosciences, India’s premier contract research organisation.
The approvals from WHO, the US Food and Drug Administration (USFDA), AFSAAPS and ANVISA elevate the research company to a higher level. These approvals are besides those from the domestic authorities, the company announced in a statement Monday.
AFSAAPS is the French agency responsible for ensuring the effectiveness, quality and proper use of all healthcare products intended for human use while ANVISA is the national health surveillance agency of Brazil.
“The approvals validate GVK BIO’s high quality systems and practices,” said upbeat Manni Kantipudi, President, GVK BIO. “GVK BIO aims to be a full service clinical research organization offering services from Bio-availability/Bio-equivalence (BA/BE) to phase I through phase IV clinical trials,” added Kantipudi.
The USFDA has inspected the facilities twice and approved several BA/BE studies conducted by GVK BIO. The BA/BE facility was also inspected and cleared by WHO after a recent audit of one of the studies. GVK BIO’s BA/BE Centre was requalified by ANVISA for the third consecutive year.
As a first step, GVK BIO has expanded and built a new state-of-the-art Bio-analytical 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.
Set up in 2001, GVK BIO is a leading contract research organisation in India. It started offering BA/BE services in 2004 and in very short time received accreditations from major international regulatory authorities.
The CPU located at Hyderabad, is one of the largest units in India for BA/BE studies with state-of-the-art infrastructure to meet global regulatory requirements.