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Immunologix Laboratories offer GLP and GCP compliant laboratory capabilities focused on biomarkers and bioanalysis of biologics, cell & gene therapy and nucleic acid based therapeutics. Our deep technical skills in ligand binding, cell-based and qPCR assays coupled with scientific consultation from our Translational Sciences team offers an integration of strategic, scientific and technical expertise that is unparalleled within our industry. This enables our team to deliver valuable scientific insights that accelerate decision-making and the overall course of drug development programs for our clients.
Quality systems compliant with GCP, GLP, EMA, FDA, OECD.
Based in the United States, serving clients globally (Americas, EU, Asia PAC).
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Torrance, CA 90501
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Mitra devices are intended as a specimen collector and for the storage and transport of biological fluids. They are CE-IVD self-certified in the UK and EU, a Class 1 IVD in Australia, Brazil & China, Class B in South Africa, and registered with health agencies in Canada, Thailand, and Ukraine. In the United States, Mitra devices are for Research Use Only (RUO). In some countries, Mitra devices may be used in clinical diagnostic laboratory systems after the laboratory has validated their complete system in compliance with relevant rules and regulations. Neoteryx operates a Quality Management System (QMS) that is based on FDA good manufacturing practices, 21 CFR 820 regulations, and ISO-13485.