CENIM announces the certification according to GLP standard
CENiMED, a leading provider of pharmacogenomic services in Germany, announces its certification according to international Good Laboratory Practice (GLP) standards, the German authorities, State Office Fri Occupational Safety, Health and Safety Technology Berlin (LAGetSi). The certification applies to the analysis pharmakogenomic for in vitro determination of genotype and phenotype and gene expression analysis. Dr. Volker Muschalek, CEO of CENiMED said: That makes CENiMED, the first and only laboratory in Europe to produce a capable, pharmacogenomic data by regulatory authorities (FDA, EMEA) accepted.For years, the agencies strongly recommend the submission of pharmacogenomic data for the approval process for new drugs. Apart from that we are very pleased that we now offer an
analysis of gene expression with Affymetrix technology as the only laboratory in Europe.Dr. Dirk Sawitzky, COO CENiMED, comments: This certification reflects the success of the highest international quality standards CENiMED and is another milestone in the development of our thriving young company. About CENiMED CENiMED GmbH - Center for Individualized Medicine - was established in 2003 as a spin-off of Universittsmedizin Charite Berlin, Germany, was founded with the intention of the results of medical research in the field of pharmacogenomics to commercialize.
The company focuses on developing and marketing products and services to the pharmaceutical industry. Thus supporting its customers CENIM from the earliest stages of drug development for post-marketingstudies. CENIM is in the biotechnology park in Berlin-Buch, Germany and has state of the art laboratories for genotyping and gene expression. Its task is the development of early diagnostic and prognostic products based on specific biological markers of patents.