Intertek Pharmaceutical Services is a world renowned GLP bioanalytical Center of Excellence dedicated to drug development.
Our Bioanalytical Center of Excellence in San Diego, CA offers Good Laboratory Practice (GLP) and non-GLP expertise in a host of assays and technologies, e.g., immunoassays, ligand binding and cell-based assays. These assays support toxicokinetics (TK) and pharmacokinetics (PK) studies, immunogenicity, and biomarker studies for preclinical and clinical development of chemical, biological and novel therapeutics and biosimilars in diverse disease areas. Our partnership with our sponsors starts from pre-clinical discovery to post-approval pharmacovigilance.
Founded in 1999, our Center is an industry pioneer in the dedicated regulated bioanalytical services community with deep expertise in regulatory guidance and vast recognized experience in bioanalytical support for drug candidates from small molecule chemical drugs to larger biological drugs. In collaboration with other Intertek pharmaceutical labs, we provide access to large molecule bioanalytical and analytical support globally. We support our customers’ drug development with analytical, bioanalytical, regulatory consulting, inspection services and more. Our Center also provides clinical kit services to support clinical trial studies with improved bioanalytical support.
Our Center of Excellence
The Center facility spans 46,000 square feet of laboratories, offices and sample storage. It is equipped with various key regulatory accepted bioanalytical technologies and platforms and is staffed by teams of leaders experienced in bioanalytical sciences for drug development and strong operational and project management teams.
In 2015, the laboratory was significantly expanded in capacity to expedite delivery of fast and cost-effective bioanalysis results for global clients. Coupled with this expansion, investment was made in new technologies that further strengthens our bioanalytical capabilities. Equipped with HR-MS, proteomics and immunochemistry and cell-based assay capabilities, our Center offers the bioanalytical approaches to biomarker discovery and development tailored to specific drug development programs.
Intertek’s Pharmaceutical Services provide total quality assurance expertise throughout the full product lifecycle, working with you at every stage of drug development.
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