Agrochemicals Together with experienced partners we provide the following services: OO regulations and procedures for dossier preparation for active ingredients and plant protection products (Annex II / Annex III ) in accordance with Directive 91/414/EEC OO dossier completeness check OO determination of study profiles OO contracting and monitoring of studies OO dossier compilation LAUS provides the necessary studies: OO physico-chemical properties OO toxicology – in vivo studies/ in vitro studies OO mutagenicity and genotoxicity OO environmental fate – ecotoxicology/ biodegradability OO field studies and residual analysis OO development of analytical methods
PROFILE: LAUS
Human pharmaceuticals / medical devices We test the effects of drugs, medical devices and medicinal products for human use. All studies are carried out according to EC/FDA/ICHguidelines, the legal requirements such as Directive 2001/83/EC and EMEA/CHMP/SWP/4447/00 and according to GLP. OO toxicology – acute, subacute and chronic studies, carcinogenicity studies, reproduction studies OO environmental fate – ecotoxicology/ biodegradability OO mutagenicity studies – bacterial reverse mutation test (Ames test), mammalian chromosome aberration test, mammalian cell micronucleus test, mammalian cell gene mutation test - mouse lymphoma-/ HPRT-test OO analytical chemistry OO extractables/ leachables Cosmetic products LAUS offers alternative methods to animal tests in the field of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetics products (Cosmetics Directive). OO in vitro skin corrosion and irritation OO in vitro eye irritation OO in vitro mutagenicity and genotoxicity OO skin sensitisation OO in vitro skin penetration OO safety evaluation OO technical product file CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1991
Foundation in Neustadt/Weinstraße, Germany
1999
First GLP certification
2006
New laboratory in Kirrweiler, Germany
2011
Opening of second laboratory building in Kirrweiler
ACCREDITATIONS Good Laboratory Practice (GLP) STAFF SELECTION Ms Jutta Paulus – Head of Quality Assurance Mr Jörg Paulus – Head of Laboratory Mr Dr Dietmar Kuhn – Managing Director Ms Anette Rudolf – Manager Business Development
Chemical Watch | Global Service Providers Guide 2012
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