News

MLM congratulates CRS – Clinical Research Services Moenchengladbach GmbH, a clinical research organization for phase I/II studies, for the successful inspection by the Brasilian Health authority, ANVISA, conducted in November 2012. The ANVISA recently issued the corresponding certificate which qualifies CRS for the conduct of pharmacokinetic and bioequivalence studies. MLM which serves as central and specialty lab for CRS Moenchengladbach has been inspected by ANVISA as well and was approved for the analysis of clinical trial samples. The ANVISA certification is an important step for the development of CRS and MLM since the conduct of studies for the Brasilian market is very attractive in the light of the positive development of Brasilia as major economy in Latin America. Brasilia has not joined the ICH process and verifies the compliance with GCP and GCLP by auditing clinical study centers with national inspectors.