15:36 uur 02-12-2016

GVK BIO lanceert GMP-conform laboratorium voor analytische diensten

HYDERABAD, India–(BUSINESS WIRE)– GVK Biosciences, een van de toonaangevende Aziatische dienstverleners voor de levenswetenschappen, heeft vandaag het Analytical Services Laboratory in Hyderabad in India gepresenteerd. Het gespecialiseerde GMP-conforme complex wordt beheerd met Laboratory Information Management Systems (LIMS). De faciliteit voldoet aan de hoogste kwaliteitseisen van toezichthouders en cliënten voor de ontwikkeling en marketing van medicijn.

GVK BIO kan zijn cliënten nu helpen met de ontwikkeling en validatie van onderzoeksmethodes en tests van API’s, voltooide producten en ruwe materialen.

 

GVK BIO Announces Launch of a GMP Compliant Analytical Services Laboratory

 

HYDERABAD, India–(BUSINESS WIRE)– 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 & 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 & 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.”

About GVK BIO

GVK Biosciences (GVK BIO) is one of Asia’s leading life-sciences services organization providing a broad spectrum of services across the R&D and manufacturing value chain with a focus on speed and quality. GVK BIO’s capabilities include Integrated Drug discovery, Chemistry, Biology, Large molecule R&D, Chemical Development, Formulation & Analytical development, Contract Manufacturing and Drug Repurposing.

GVK BIO’s diverse portfolio of more than 400 customers include the world’s top 10 corporations in the field of Pharmaceuticals, Biotechnology and Agrochemicals along with leading Academic institutions. Please visit us at www.gvkbio.com to learn more.

Contacts

GVK Biosciences
Shankar Chelluri, Director – Corporate Communications
+91 40 6692 1822
shankar.chelluri@gvkbio.com

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