Issuing Body Quality and Accreditation Institute, Centre for International Accreditation
Issuing Body Country INDIA
Issuing Body Website http://www.qai.org.in/
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Eurofins BioPharma Product Testing India is a trusted partner for cGMP-compliant analytical testing solutions, supporting pharmaceutical, biopharmaceutical, and medical device companies across the product development lifecycle. Our comprehensive capabilities include Analytical Method Development and Validation, Nitrosamine Impurity Testing, Extractable & Leachable Studies, Stability Testing, Microbiology Testing, Elemental Impurity Analysis, Genotoxic Impurity Assessment, Residual Solvent Testing, Forced Degradation Studies, Dissolution Profiling, Release Testing, Packaging Material Analysis, and ICH/VICH Stability Studies.
Established in Bengaluru and continuously expanding its scientific and operational capabilities, Eurofins BioPharma Product Testing India has evolved into a key part of the global Eurofins BioPharma Product Testing network. The facility has strengthened its expertise through successive investments in advanced analytical technologies, expanded laboratory infrastructure, enhanced quality systems, and successful regulatory inspections, including receipt of an Establishment Inspection Report (EIR) from the US FDA. Today, the site serves as a strategic testing hub, delivering high-quality analytical services to support global pharmaceutical and biopharmaceutical development programmes.
Backed by the global Eurofins network of more than 45 BioPharma Product Testing laboratories across 20+ countries, our Bengaluru facility combines scientific expertise with state-of-the-art instrumentation, including HPLC, GC-HS, LC-MS/MS, ICP-MS, GC-MS/MS, Ion Chromatography, FTIR, UV Spectroscopy, pXRD, and walk-in stability chambers. Supported by a robust Quality Management System encompassing analyst qualification programmes, deviation and OOS management, CAPA implementation, change control, computerised system validation, 21 CFR Part 11-compliant electronic systems, and data integrity controls, we help clients ensure product quality, regulatory compliance, and successful global market access. Additionally, the facility is certified to ISO 17025:2017 for Medical Devices, Biomaterials, and Ophthalmic Devices Testing, and ISO 9001:2015 for Contract Services in Test, and Stability Study of Pharmaceutical Intermediates, NCEs, and APIs.
21 & 22, Peenya Industrial Area Phase II,Bangalore,560058, India
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Issuing Body Quality and Accreditation Institute, Centre for International Accreditation
Issuing Body Country INDIA
Issuing Body Website http://www.qai.org.in/
Issuing Body Food and Drug Administration
Issuing Body Country US - United States
Issuing Body Website https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder
Issuing Body National Accreditation Board for Testing and Calibration Laboratories
Issuing Body Country IN - India
Issuing Body Website https://nablwp.qci.org.in
Issuing Body Drug Control Department of Karnataka ( India)
Issuing Body Country IN - India
Issuing Body Website https://drugs.karnataka.gov.in