Our scientists can conduct large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory, as well as preclinical toxicology and vaccine testing at our AAALAC accredited facilities. Our scientists regularly work with clients developing drug delivery devices, single-use systems, medical, and pharmaceutical packaging. Smithers also conducts environmental risk assessment studies to satisfy all regulatory requirements globally.
Drug Development Services
Smithers supports the development of biologics and vaccines from discovery through phase IV, with expertise that includes bioassays and high-sensitivity assays. Services include development, validation and sample analysis for pharmokinetic and toxokinetic assays, antidrug antibody assays, bioassays and biomarker assays.
Smithers also supports pharmaceutical development through the identification of safety and/or efficacy outcomes. Studies are conducted across multiple species. Our expertise includes single dose to two-year general toxicology studies, vaccine safety testing, toxicokinetics, and infusion studies.
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Environmental Assessment Services
Smithers performs environmental and consumer safety contract research and regulatory services for the pharmaceutical and animal health industries. We have performed standard guideline and higher-tiered environmental studies for over 45 years.
Offerings include environmental fate, animal metabolism, aquatic and terrestrial ecotoxicology, residue, analytical, and product chemistry, and regulatory risk assessment.
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Packaging Services including Extractables and Leachables Studies
Smithers Rapra and sister company Smithers Pira regularly work with clients developing drug delivery devices, single use systems, medical and pharmaceutical packaging. The teams support pharmaceutical and biopharmaceutical companies with expert advice, troubleshooting and testing services for containers used within these industries. This includes primary container closure systems such as metered dose inhalers, pre-filled syringes, secondary packaging and single-use systems e.g. bioprocessing containers. Our experienced teams will provide advice, guidance and recommendations as well as delivering test data and supporting global regulatory submissions.
Visit Smithers Rapra for an overview of services offered by both organizations