GVK BIO announces launch of a GMP compliant Analytical Services Laboratory

India Infoline News Service | Mumbai | December 01, 2016 16:42 IST

GVK BIO can now offer its clients, development and validation of research methods and compendial testing of API, finished products and raw materials.

Pills Spilling From Bottle
GVK Biosciences, one of Asia’s leading life sciences service organizations today announced the launch of an Analytical Services Laboratory in Hyderabad, India. 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 & optimization
  • Identification and isolation of trace level impurities
  • Method development and quantification of genotoxic impurities and heavy metals
  • Isolation of impurities by Prep LC and SFC
  • Characterization of polymorphs/pseudo polymorphs
  • Stability studies for drug product and drug substance as per ICH guidelines
  • Dissolution profile
  • Extractable and leachable study & quantification
  • 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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