![]() |
In regulatory toxicology CERB offers the whole range of studies in different species including rodents, rabbits, dogs and primates typically required for new drug development and chemical safety testing. We have a wide range of facilities and experience enabling us to perform routine as well as specialised tests. The quality and reliability of CERB’s performance is reflected by the many ongoing and long-lasting collaborations maintained with leading international companies worldwide. For the chemical industry CERB conducts all of the in vivo studies required for both the European Union Notification of New Substances (NONS) and for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). The studies take place in state-of-the-art laboratories, according to Annex V, Part B of the Dangerous Substances Directive 67/548/EEC and according to the respective testing guidelines released by the OECD. All work is performed in a GLP-certified environment. All procedures and facilities are routinely audited and maintained under GLP-regulations. A modern and well equipped Analytical Chemistry unit provides study related support as for example formulation analyses and plasma analyses of compound levels (HPLC, GC, LCMS/MS). Full development of new analytical methods can be offered as well as adaptation and validation of methods provided by the Sponsor. Data capture and analysis is to a great extent computerised using validated software. Genotoxicity testing as required by regulation is also part of our safety evaluation package. These tests are performed at the Institut Pasteur de Lille under CERB monitoring, making full use of the synergistic potential provided by this highly specialised laboratory. |