WILMINGTON, N.C.--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.
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 12,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.
Except for historical information, all of the statements, expectations and assumptions, including statements, expectations and assumptions about the ANVISA certification, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based and could cause actual results to differ materially from the forward-looking statements. Other important factors that could cause future results to differ materially include the following: risk of losing and the cost to maintain the ANVISA certification; rapid technological advances that make our services less competitive; competition in the outsourcing industry; compliance with drug development regulations; PPD's ability to win new business; overall global economic conditions; economic conditions, research and development spending, and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; consolidation in the pharmaceutical and biotechnology industries; loss, delay or modification of large contracts; higher-than-expected cancellation rates; the rate of conversion of backlog into revenue; actual operating performance; the ability to control SG&A spending; risks associated with acquisitions and investments; the ability to attract, integrate and retain key personnel; and changes in the regulation of the drug development process. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable law. These forward-looking statements should not be relied upon as representing PPD's estimates or views as of any date subsequent to the date hereof.