Lincoln, Neb.-based Celerion, a provider of early-stage drug development solutions, has announced that its clinical research operations in Belfast, Northern Ireland, and its clinical research and bioanalytical services operations in Lincoln, Neb., 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 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 also has been certified by the U.K.’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.