Our team helps medical device and pharmaceutical product manufacturers bring innovative, compliant and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA.
Our experienced medical device and extractables and leachables (E&L) testing teams will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO.
Smithers also supports the pharmaceutical industry and the development of biologics and vaccines from discovery through phase IV, with expertise that includes bioassays and high sensitivity assays. Our scientists have expertise in large molecule bioanalysis assay development, validation, and sample analysis.
Company’s Keywords:
dart, immunogenicity, toxicokinetics & pharmacokinetics, sample analysis for pktk, toxicology, biomarker assays, safety pharmacology, ligand binding, bioassays, cell & gene therapies testing, vaccine & antiviral testing, infusion testing, bioanalytical testing, experimental medicineefficacy models
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