Vanta Bioscience, a US-owned and operated preclinical Contract Research Organisation (CRO), announced that its toxicology facility in Chennai has received Good Laboratory Practice (GLP) accreditation from the National GLP Compliance Monitoring Authority (NGCMA), a branch within the Government of India, after successfully clearing preliminary and final audits.
NGCMA administers the GLP programme in India as a member state and participant in the principles of GLP charter of the Organisation for Economic Co-operation and Development (OECD). As a result, data generated at Vanta Bioscience is now recognised by member countries around the world, including: Canada, Germany, Japan, and the US. This certification covers the areas of acute toxicology, genotoxicology, subacute toxicology, sub-chronic toxicology, chronic toxicology (carcinogenicity), and reproductive toxicology.
Vanta Bioscience is a full service life-science R&D outsourcing company with research laboratories in Chennai, India, and offices in Brussels, Belgium and West Des Moines, Iowa, US complying with OECD GLP, ISO, AAALAC and US FDA GLP (21 CFR Part 58) guidelines, Vanta Bioscience provides a broad and integrated portfolio of services covering pharmacology, safety assessment, chemistry and CMC / clinical consulting and project management. These services are designed to assist our global partners in shortening the cycle and reducing the cost of R&D in the pharmaceutical, biotech, medical device, cosmetics, animal feed, nutraceutical / food supplement, feed additive and chemical industries.
“The receipt of this accreditation is an acknowledgment of the high level of GLP compliance and the high quality of Vanta Bioscience’s research program, which are the core foundation of our new, world class research facility,” said Keith Bostian, President and CEO, Vanta Bioscience. “GLP certification from an OECD member state is a significant milestone in our ability to offer international quality services to our clients for regulatory submissions worldwide, including US FDA, EMA, MHLW, CDSCO, EPA, EDQM and EFSA.”
Vanta Bioscience has a growing list of accreditations in addition to the recently acquired GLP certification, further attesting to the compliance of its quality systems. Vanta Bioscience obtained accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) in October, 2011, and holds an Occupational Health and Safety Advisory Services certificate (OHSAS 18001) issued by TÜV SÜD and External Quality Assessment (EQAS) certificates for hematology and biochemistry issued by Bio-Rad Laboratories in the UK.
EP News Bureau