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GVK BIO Launches Analytical Services Lab in India

To offer development and validation of research methods and compendial testing of API, finished products and raw materials

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By: Kristin Brooks

Managing Editor, Contract Pharma

GVK Biosciences has launched an Analytical Services Lab in Hyderabad, India. The dedicated GMP facility is managed by validated Laboratory Information Management Systems (LIMS), and is compliant with quality standards required by regulatory agencies for the development and marketing of medicinal products.
 
GVK BIO can now offer development and validation of research methods and compendial testing of API, finished products and raw materials. The analytical services span analytical method development, validations and optimization; identification and isolation of trace level impurities; method development and quantification of genotoxic impurities and heavy metals; characterization of polymorphs/pseudo polymorphs; stability studies for drug product and drug substance as per ICH guidelines; dissolution profile; extractable and leachable study & quantification; and particle size distribution analysis.
 
Dr. Sudhir Kumar Singh, president, Discovery and Development Services, GVK BIO said, “Global Pharma is looking at one-stop solutions and much of the cGMP testing is outsourced. Integrated Analytical Services is a strategic fit for GVK BIO and lets our customers focus on their core area of R&D and Manufacturing. We have invested in best-in-class equipment and experienced talent pool enabling us to extend a broad range of consultative high quality Analytical testing services that comply with global regulatory requirements.”

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