Celerion receives ANVISA certification
Brazilian Regulatory Agency Approves Celerion Facilities in both North America and Europe to Conduct Clinical Research and Bioanalytical Services.
(Lincoln, NE; Jun 9, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce that its clinical research operations in Belfast, Northern Ireland UK, and its clinical research and bioanalytical services operations in Lincoln, Nebraska USA, have been certified by the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – ANVISA).
ANVISA provides regulatory approval for drugs and other products seeking to enter the large and growing Brazilian market. ANVISA-certified service providers are uniquely qualified to help clients clear a key hurdle to access one of the fastest-growing major pharmaceutical markets in the world.
“The approval of ANVISA continues to demonstrate the high quality work done at Celerion.” said Susan Thornton, President and CEO. “By earning ANVISA certification to conduct early clinical studies and bioanalytical research for compounds destined for Brazil, Celerion is now able to better serve our clients’ growing needs in this high–growth, emerging market.”
In addition to ANVISA certification, Celerion’s Belfast, facility has also been certified by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The facility has received both Standard and Supplementary Accreditation from the MHRA, which certifies that the general standards for study participant safety and access to emergency medical response have been met. The MHRA accreditation attests to Celerion’s commitment to participant safety.
Celerion is the premier provider of innovative early stage clinical research solutions. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com.