MDS’ sites gain Brazilian regulatory certification
Clients using the sites certified by Brazil’s Agencia Nacional de Vigilancia Sanitaria (ANVISA) will have the review of their submissions expedited, helping them get their products to market quicker.
Furthermore, ANVISA only accepts bioavailability/bioequivalence (BA/BE) work that is completely performed at certified sites, Manon Vranderick, vice president for quality and compliance in early stage development, told Outsourcing-Pharma.
Vranderick added that MDS sought ANVISA certification at the request of a major client with products aimed at the Brazilian market. Gaining approval puts MDS among a small group of contract research organisations (CRO) in the US and UK with certification.
ANVISA has accredited MDS’ sites in Belfast, Northern Ireland, making it the only CRO with certification in the UK, and Lincoln, Nebraska, US. This makes MDS only the second CRO to gain ANVISA certification in the US and Vranderick believes this is because of the difficulties it entails.
Vranderick explained that “the certification process is time-consuming, demanding and expensive”, with MDS spending six months preparing applications that require very detailed information. Following this week long final inspections were conducted at each site.
This commitment was made for a major client that is targeting the Brazilian market, which is projected to be worth more than $18bn (€12.3m) by 2012.
Vranderick added that MDS has the major certifications and will seek accreditation with additional regulatory agencies when it is “necessary to provide a competitive advantage to [its] clients”.
The ANVISA certification is the second regulatory accreditation MDS’ Belfast site has gained in recent months. In July the site was granted standard and supplementary accreditation from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).