Tentamus Pharma & Med Deutschland GmbH is an association of GMP-certified and ISO-accredited contract laboratories in Germany with sites in Bad Kissingen (formerly BLS-Analytik), Karlsruhe (formerly Tentamedix) and Oldenburg (formerly DSI-Pharm). The laboratories carry out chemical, physico-chemical, micro- and molecular biological and cell biological testing for active substances, medicinal products and medical devices.
For medical devices Tentamus tests biocompatibility and biological safety in accordance with the current ISO 10993 standards and OECD guidelines — its speciality is in-vitro-based test systems for cytotoxicity, irritation, sensitisation and genotoxicity. Added to this are bioburden and endotoxin determination, functional bioassays and instrumental analysis with AAS, ICP-MS and gas chromatography.
For medicinal products, starting materials, in-process products, active substances and finished medicinal products are tested in compliance with GMP using pharmacopoeial methods or individual specifications; Qualified Persons carry out batch releases and EU retests on behalf of customers. An experienced team stands for transparent procedures, valid results and meaningful documentation.
