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Pharmaceutical Product Development, LLC (PPD) today announced its bioanalytical operation has been certified by Brazil’s Agencia Nacional de Vigilancia Sanitaria (ANVISA), validating that PPD meets the agency’s stringent biopharmaceutical safety guidelines and allowing the company to conduct bioanalytical work on its clients’ compounds that will be marketed in Brazil.
The governmental regulatory agency will only accept or approve products for market that have had all bioavailability/bioequivalence assay work performed at a certified facility.
“This certification uniquely positions us to conduct bioanalysis on behalf of our clients who plan to market their products in Brazil and enhances our portfolio of laboratory services in Latin America,” said Bob Nicholson, vice president of bioanalytical labs for PPD. “Having established our first office in Latin America in Brazil in 1996, we have a thorough understanding of the country’s drug development environment. The long-standing history of our bioanalytical labs, coupled with our ability to offer more than 450 validated assays, enables us to provide clients expedited timelines, important cost efficiencies and high-quality study data.”
PPD has a staff of more than 700 people in Latin America at offices in Argentina, Brazil, Chile, Columbia, Mexico and Peru. PPD provides a wide range of services and expertise to assist clients in designing, planning and implementing clinical development programs.
PPD’s bioanalytical labs in Middleton, Wis., and Richmond, Va., provide accurate, high-quality results across all phases of drug development and commercialization. Bioanalytical services include comprehensive, state-of-the-art assay development, transfer, validation and sample analysis in multiple biological species and matrices, as well as metabolite identification. The labs have expertise with many validated methods to quantitate all types of compounds using LC/MS/MS, HPLC and immunochemistry.
ANVISA is responsible for drug registration and licenses for pharmaceutical laboratories and other companies within the pharmaceutical production flow. The agency also is responsible for establishing regulations that apply to clinical trials and drug pricing. Together with states and municipalities, the agency inspects factories, monitors the quality of drugs, exercises post-marketing surveillance, takes pharmacovigilance actions, and regulates drug promotion and marketing.