CENiMED GmbH, the leading provider of pharmacogenomic services in Germany announces its certification according to international Good Laboratory Practice (GLP) standard by the German authorities, Landesamt fГјr Arbeitsschutz, Gesundheitsschutz und technische Sicherheit Berlin (LAGetSi). The certification applies to pharmakogenomic analyses for the in-vitro determination of the genotype and phenotype as well as to gene expression analyses.
Dr. Volker Muschalek, CEO of CENiMED GmbH, states: "This makes CENiMED GmbH the first and only laboratory in Europe which is able to generate pharmacogenomic data accepted by the regulatory agencies (FDA, EMEA). Since years the agencies strongly recommend the submission of pharmacogenomic data for the approval process of new drugs. Apart from that we are very happy that we can now also offer gene expression analyses with Affymetrix technology as the only laboratory in Europe."
Dr. Dirk Sawitzky, COO of CENiMED GmbH comments: „This certification reflects the successful implementation of highest international quality standards at CENiMED GmbH and is another milestone in the flourishing development of our young company."
About CENiMED GmbH
CENiMED GmbH - Centre for Individualised Medicine - was established in 2003 as a spin-off of the Charité Universitätsmedizin Berlin, Germany, with the intention to commercialise the results of medical fundamental research in the field of pharmacogenomics. It is a leading bio-medical company in the area of pharmacogenomic services
The company focuses on the development and marketing of services and products for the pharmaceutical industry. Herewith, CENiMED supports their clients from the early phases of drug development to post marketing studies.
CENiMED is located in the Biotech Park, Berlin-Buch, Germany and possesses state-of-the-art genotyping and gene expression laboratories. Its mission is the development of early diagnostic and prognostic products on the basis of patent specific biomarkers.
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