Pharmaceutical

Smithers offers a comprehensive range of pre-clinical and clinical services to support the development of drug delivery devices, medical and pharmaceutical packaging; environmental risk assessment; and all phases of drug development.

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