The laboratory is GMP-compliant with highest quality standards required by regulatory bodies and clients for the development and marketing of medicinal products
GVK Biosciences has launched an analytical services laboratory in Hyderabad. The dedicated GMP-compliant facility is managed by validated Laboratory Information Management Systems (LIMS). It is compliant with the highest quality standards required by regulatory bodies and clients for the development and marketing of medicinal products.
GVK BIO can now offer its clients, development and validation of research methods and compendial testing of API, finished products and raw materials.
The analytical services expertise span across: analytical method development, validations and optimisation, identification and isolation of trace level impurities, method development & quantification of genotoxic impurities and heavy metals, isolation of impurities by Prep LC & SFC, characterisation of polymorphs/ pseudo polymorphs, stability studies for drug product and drug substance as per ICH guidelines, dissolution profile, extractable and leachable study and 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.”
EP News Bureau
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