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Preclinical Drug Development
SRI International's pharmaceutical development teams provide clients with a wide range of services for moving new drug candidates from the laboratory into clinical testing and to the marketplace. The only full-service contract research organization based on the West Coast, SRI works with large and small pharmaceutical and biotechnology clients, including global pharmaceutical companies and start-up biotechnology ventures. We also serve the nonclinical needs of the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH), and the National Institute of Aging (NIA).
Scope of Services
With services ranging from comprehensive drug safety evaluations to scale-up processing of prototype clinical trial materials (CTMs), SRI helps clients meet their product development objectives. We provide clients with more than 40 years of expertise and facilities equipped with sophisticated scientific instrumentation. We have AAALAC-accredited animal facilities and a modern functional manufacturing facility including an aseptic processing suite. All of SRI's pharmaceutical development services meet worldwide stringent regulatory requirements. SRI studies are conducted under Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations. For biotech and pharmaceutical clients that need specialized expertise in the discovery phase, SRI provides discovery services for target research initiatives or as an ongoing development resource.
Our key development services include Drug substance preparation
Analytical chemistry and quality control
Formulation design and development
Manufacturing of preclinical and clinical trial materials
Pharmacokinetics and metabolism
Toxicology
Preclinical Development Plan (PDP) preparation
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Last Updated
Feb 25, 2010
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