22 March 2013 | News | By BioSpectrum Bureau
PPD's bioanalytical operation has received the certification
Singapore: Pharmaceutical Product Development's (PPD) 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 only accepts or approves 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 Mr 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."