List of GLP Test Facilities / Test Sites Good Laboratory Practice (GLP) Test Facilities / Test Sites in the Monitoring Programme, GERMANY (as to May 2015) GLP Federal Bureau: List of GLP Test facilities/ Test Sites, Germany (2015-05-29) page 1/14 List of GLP Test Facilities / Test Sites Explanation areas of expertise: 1 - physical-chemical testing 2 - toxicity studies 3 - mutagenicity studies 4 - environmental toxicity studies on aquatic and terrestrial organisms 5 - studies on behaviour in water, soil and air; bioaccumulation 6 - residue studies 7 - studies on effects on mesocosms and natural ecosystems 8 - analytical and clinical chemistry testing 9 - other studies (specify) GLP Test Facilities/Test Sites in Germany Test Facility/ Test Site A. Menarini Research Business Service GmbH Analytische Laboratorien F&E Address 12489 Berlin Glienicker Weg 125 Area of Expertise 1-8 A&M Labor für Analytik und Metabolismusforschung Service GmbH 50126 Bergheim Kopernikusstraße 25 8 AbbVie Deutschland GmbH & Co. KG Betriebsstätte Ludwigshafen 67061 Ludwigshafen Knollstraße 2-8 ACC 63849 Leidersbach Analytical Clinical Concepts GmbH Schöntalweg 9 8 Across Barriers GmbH 66123 Saarbrücken Science Park 1 1-8-9 (in vitro toxicity studies with cell systems and tissues) advanceCOR GmbH 82152 Martinsried Lochhamer Straße 29a (RG) 9 (ELISA determinations in serum/ plasma of animals/humans) Agrartest GmbH 65326 Aarbergen-Panrod 6 Palmbachstraße 37 agro-check Dr. Teresiak & Erdmann GbR Landwirtschaftliche Forschung, Entwicklung, Beratung 16833 Lentzke Dorfstraße 15 4-9 (field trials for residue studies - application/sampling plants, soil) Allessa GmbH Analytik 60386 Frankfurt/Main Alt-Fechenheim 34 1-5 Almirall Sofotec GmbH Prüfstandort/ test site 61352 Bad HomburgBenzstraße 1- 3 9 (closed archiv) GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) page 2/14 List of GLP Test Facilities / Test Sites Test Facility/ Test Site AlzChem AG Abt. Analytik Address 83308 Trostberg Dr. Albert-FrankStraße 32 Area of Expertise 1-6-8 Amgen Research (Munich) GmbH 81477 München Staffelseestraße 2 8-9 (immunology; bioactivity testing) Analytik Consulting Institut (ACI) GmbH 41468 Neuss Am Röttgen 126 1-8 Analytisches Zentrum Biopharm GmbH Berlin 12681 Berlin Bitterfelder Straße 19 1-8 AQura GmbH 45764 Marl Paul-Baumann-Straße 1 Gebäude 1336 B/16 1-8 Celonic GmbH 52428 Jülich Karl-Heinz-BeckurtsStraße 13 12205 Berlin Unter den Eichen 87 8 BASF SE Crop Protection – Ecology and Environmental Analytics 67117 Limburgerhof Speyerer Straße 2 1-4-5-6-7-8 BASF SE Experimentelle Toxikologie und Ökologie 67056 Ludwigshafen 1-2-3-4-5-8-9 (biochemical and pathological examinations concerning mode of action) BASF SE Kompetenzzentrum Analytik BASF SE Sicherheitstechnik – L 511 Bavarian Nordic GmbH 67056 Ludwigshafen 1 67056 Ludwigshafen 1 82152 Martinsried Fraunhoferstraße 13 9 (efficacy testing of vaccines with rodents; immunological evidence of virus specific antibody and ELISA medium PRNT (plaque reduction neutralization test); determination of virus concentration by titration assay) 9 (animal part of GLP-obligatory studies) 1-4-5-6-7-8 BAM Bundesanstalt für Materialforschung und –prüfung Abt. 2 – Chemische Sicherheitstechnik Bayer Animal Health GmbH D-GCD-Animal Center Bayer CropScience AG Development – Environmental Safety-Testing (BCS-D-EnSa-Testing) 40789 Monheim Alfred-Nobel-Straße 50 40789 Monheim Alfred-Nobel-Straße 50 GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) 1 page 3/14 List of GLP Test Facilities / Test Sites Test Facility/ Test Site Bayer CropScience AG Development – Formulation Technology – Analysis & Services Monheim Address 40789 Monheim Alfred-Nobel-Straße 50 Gebäude 6820 Area of Expertise 1 Bayer CropScience AG EnSa Ecotoxicology 65926 Frankfurt/Main Industriepark Höchst, Gebäude H872 4 Bayer CropScience AG Human Safety – Residue Analysis (BCS-R&D-D-HS-RA) 40789 Monheim Alfred-Nobel-Straße 50 1-5-6-8 Bayer CropScience AG 40789 Monheim Research – Research Alfred-Nobel-Straße 50 Technologies – Analytics Monheim (BCS-R-RT-AM) 1 Bayer CropScience AG Research Technologies – Analytics Frankfurt 65926 Frankfurt/Main Industriepark Höchst 1 Bayer Pharma AG GDD-GED Toxikologie Pharma-Forschungszentrum 42096 Wuppertal 1-2-3-9 (biochemical toxicity; short term cancerogenicity; immunotoxicity; safety pharmacology) Bayer Pharma AG Nonclinical Drug Safety (NDS) 13353 Berlin Müllerstraße 170-178 1-2-3-4-5-8 Bayer Technology Services GmbH Process Technology Process and Plant Safety Sicherheitstechnisches Labor 51368 Leverkusen Gebäude B 407 1 Bioassay Labor für biologische Analytik GmbH 69120 Heidelberg Im Neuenheimer Feld 515-519 2 BioChem agrar Labor für biologische und chemische Analytik GmbH 04827 Machern OT Gerichshain Kupferstraße 6 4-5-6 BioChem agrar GmbH Niederlassung Agroplan 47574 Goch-Nierswalde Berliner Straße 75 5-6 BioChem GmbH 76185 Karlsruhe Daimlerstraße 5b 1-9 (molecular biological test) biochemA GmbH 79359 Riegel a. K. Im Oberwald 19b 8 GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) page 4/14 List of GLP Test Facilities / Test Sites Test Facility / Test Site BioGenius GmbH Address 51429 Bergisch Gladbach Technologie Park Haus 56 Friedrich-Ebert-Straße Area of Expertise 1 BioMedVet Research GmbH 29664 Walsrode Südkampen 31 Biopharm GmbH 69115 Heidelberg Czernyring 22 2-9 (biochemicalpharmacological efficacy testing; pharmacokinetics/metabolism (animal phase); residue studies on pharmacologically active substances in food-producing animals (animal phase); safety pharmacology; safety and efficacy tests of vaccines) 1-8 BIOPIOR GmbH Prüfstandort/ test site 30880 Laatzen Steinbrink 47 9 (histo- and cytopathological assessment of tissue specimens and smears in examinations of toxicopathological studies) BIOSERV Analytik und Medizinprodukte GmbH 18059 Rostock Dr.-Lorenz-Weg 1 1-2-3-9 (biological and microbiological in vitro safety tests on medical devices and pharmaceuticals) Biotest AG Global Research - Bioanalytics 63303 Dreieich Landsteiner Straße 5 8 BIOTRONIK SE & Co. KG 12359 Berlin Woermannkehre 1 1-9 (in vitro cytotoxicity testing) Boehringer Ingelheim Pharma GmbH & Co. KG Betriebsstätte Biberach 88397 Biberach an der Riss Birkendorfer Straße 65 2-3 Boehringer Ingelheim Veterinary Research Center GmbH & Co. KG 30559 Hannover Bemeroder Straße 31 9 (safety studies of vaccines in farm animals) BSL BIOSERVICE Scientific Laboratories GmbH 82152 Planegg Behringstraße 6-8 Charles River Biopharmaceutical Services GmbH 51105 Köln Gottfried-HagenStraße 20 21683 Stade Stader Elbstraße 26 - 28 2-3-9 (microbiological safety studies; efficacy testing with cell cultures) 9 (viral and prion clearance studies) Cheminova Deutschland GmbH & Co. KG GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) 1-5-6 page 5/14 List of GLP Test Facilities / Test Sites Test Facility/ Test Site CIP Chemisches Institut Pforzheim GmbH Address 75175 Pforzheim Schulberg 17 Area of Expertise 1-6-8 Clariant Produkte (Deutschland) GmbH Clariant Analytical Services Rhein-Main – R&D Analytics Team Biologie Prüfstandort/ test site 65926 Frankfurt/Main Industriepark Höchst Gebäude D562 9 (closed GLP-archive) CleanControlling Medical GmbH & Co. KG 78576 EmmingenLiptingen Rötenstraße 1 65926 Frankfurt/Main Industriepark Höchst Gebäude G 830 9 (testing for biological, chemical and toxic contaminations) consilab Gesellschaft für Anlagensicherheit mbH 1-5 Covance Preclinical Services GmbH 48163 Münster Kesselfeld 29 2 CRS Clinical Research Services Mannheim GmbH Bereich Bioanalytik 67269 Grünstadt Richard-WagnerStraße 20 8-9 (determination of contents; stability-/homogeneity testing) CSL Behring GmbH Virus Safety Development 35041 Marburg Emil von Behring Straße 76 9 (virus validation studies) CSL Behring GmbH Preclinical R&D Operations Support 35041 Marburg Emil von Behring Straße 76 Gebäude Z 25 8-9 (ELISA studies) Currenta GmbH & Co. OHG 51368 Leverkusen CHEMPARK – Gebäude K 46 1-4-5-6-8 Cytocentrics Bioscience GmbH 18059 Rostock Joachim-JungiusStraße 9 9 (studies of interaction between pharmaceutical drugs and human ion channels) Dienstleistungszentrum Ländlicher Raum (DLR) – Rheinpfalz 67435 Neustadt an der Weinstraße Breitenweg 71 4-5-6 DR. U. NOACK-LABORATORIEN 31157 Sarstedt Käthe-Paulus-Straße 1 1-4-5-6-7-9 (studies of genotoxicity and mutagenicity in vitro) Dr. Willmar Schwabe GmbH & Co.KG 76227 Karlsruhe Willmar-SchwabeStraße 4 1-8 GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) page 6/14 List of GLP Test Facilities / Test Sites Test Facility/ Test Site ECT Oekotoxikologie GmbH Address 65439 Flörsheim Böttgerstraße 2-14 Area of Expertise 4-5-7 EUFETS GmbH Prüfstandort/ test site 55743 Idar-Oberstein Vollmersbachstraße 66 9 (archiving study documentation of former test facility) Eurofins Agroscience Services Chem GmbH 21079 Hamburg Grossmoorbogen 25 6 Eurofins Agroscience Services EcoChem GmbH 75223 NiefernÖschelbronn Eutinger Straße 24 1-4-5-6-7-8 Eurofins Agroscience Services GmbH 21684 Stade Carl-Goerdeler-Weg 5 5-6-7-9 (processing studies; archiving) Eurofins Dr. Specht Laboratorien GmbH 21079 Hamburg Grossmoorbogen 25 6 Eurofins GeneScan GmbH 79108 Freiburg Engesserstraße 4 9 (molecular biological testing) Eurofins Medigenomix GmbH 85560 Ebersberg Anzinger Straße 7a 9 (DNA sequencing for genetic typification; safety studies of GMOs, microorganisms, viruses, cell banks, cell lines) F.W. Klever GmbH 84168 Aham Hauptstraße 20 1 Field Research Support 31515 Wunstorf Potts Kamp 8 6 (field trials) Forschungszentrum Jülich GmbH Institut für Bio- und Geowissenschaften, IBG-3: Agrosphäre 52428 Jülich Wilhelm-Johnen-Straße 5 Fraunhofer Institut für Grenzflächen 70569 Stuttgart und Bioverfahrenstechnik Nobelstraße 12 Molekulare Biotechnologie – Molekulare Zelltechnologie 9 (cell-based assays to detect biological parameters [biological activity, pyrogenic and viral residues, immunogenicity tests]) Fraunhofer Institut für Molekularbiologie und angewandte Oekologie (IME) Bereich Angewandte Ökologie 1-3-4-5-6-7 57392 Schmallenberg Auf dem Aberg 1 GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) page 7/14 List of GLP Test Facilities / Test Sites Test Facility/ Test Site Fraunhofer Institut für Toxikologie und Experimentelle Medizin (ITEM) Address 30625 Hannover Nikolai-Fuchs-Straße 1 Area of Expertise 1-2-3-5-8-9 (safety pharmacology of the lung; molecular toxicological and molecular biological studies on chemicals, pesticides and pharmaceutically active substances) Fraunhofer Institut für Zelltherapie und Immunologie AG Zelltechnik/GLP 04103 Leipzig Perlickstraße 1 9 (safety tests of ATMPs - immunotoxicity/immunogenicity in vitro / in vivo) FREY-TOX GmbH 04916 Herzberg/Elster Osteroda 38 Grünenthal GmbH 52078 Aachen Zieglerstraße 6 2-9 (in vitro testing of skin irritating/corrosive properties; biological safety studies of medical devices) 8-9 (pharmacokinetics) GTF Gesellschaft für Therapeutische Forschung mbH Prüfstandort/ test site 90562 NürnbergHeroldsberg Paul-Ehrlich-Straße 19 9 (bioequivalence, bioavailiability; pharmacokinetics/-dynamics and toxicokinetics by ELISA and LC-MS/MS detection in biological materials) Harlan Cytotest Cell Research GmbH 64380 Roßdorf In den Leppsteinswiesen 19 2-3-8 Henkel AG & Co. KGaA HSA Corporate Scientific Services 40589 Düsseldorf Henkelstraße 67 1-9 (Adsorption/Desorption following OECD Guideline 121 and Hydrolysis following OECD Guideline 111) Hetterich Fieldwork GbR Ingenieurbüro für landwirtschaftliche Feldversuche Prüfstandort/ test site Hexal AG 97359 Schwarzach Bamberger Straße 50 9 (field trials of residue studies) 82041 Oberhaching Keltenring 1+3 9 (immonoassays for pharmacokinetics, pharmacodynamics and immunogenicity) Hydrotox GmbH 79111 Freiburg Bötzinger Straße 29 3-4-5 IBACON Institut für Biologische Analytik und Consulting GmbH IDT Biologika GmbH 64380 Roßdorf Arheiliger Weg 17 1-4-5-6 06861 Dessau-Roßlau Am Pharmapark 9 (safety tests according to Annex I of the Directive 2001/82/EG) GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) page 8/14 List of GLP Test Facilities / Test Sites Test Facility/ Test Site IMGM Laboratories GmbH Address 82152 Martinsried Bunsenstraße 7a IMTR Institute of Medical Technology and Research GmbH 39343 Rottmersleben Thomas-Müntzer-Platz 1 Institut für Gewässerschutz Mesocosm GmbH 35315 Homberg an der Ohm Neu Ulrichstein 5 Am Forschungszentrum Neu Ulrichstein 16321 Bernau Weißenseer Straße 36 4-7-9 (metabolism / residue analytic for farm animals - application, tests, section) Institut Kuhlmann GmbH Analytik-Zentrum Ludwigshafen 67071 Ludwigshafen Hedwig-Laudien-Ring 3 1 Intertek Food Services GmbH 35440 Linden Philipp-Reis-Straße 4 1 IPM Biotech GmbH 22339 Hamburg Lademannbogen 61 Iron Mountain Deutschland GmbH GLP-Auftragsarchiv Prüfstandort/ test site 44805 Bochum Harpener Hellweg 31 9 (analysis of immunogenicity from biopharmaceuticals by assignation of neutralize and effectual antibody as well as PK/PD analysis (RIA, EIA, BiaCore, Bioassay)) 9 (GLP contract archive) ISP Biochema Schwaben GmbH 87700 Memmingen Luitpoldstraße 32 1 Julius Kühn Institut (JKI) – Bundesforschungsinstitut für Kulturpflanzen Wirbeltierforschung (WF) Labor Dr. Merk & Kollegen GmbH 48161 Münster Toppheideweg 88 4 88416 Ochsenhausen Im Braunland 1 8-9 (biological and microbiological safety and efficacy of medical devices and pharmaceuticals) Institut für Veterinär-Pharmakologie und Toxikologie (IVPT) GmbH Labor L+S AG 97708 Bad Bocklet Mangelsfeld 4, 5, 6 LAFAA 23611 Bad Schwartau Laboratory for Contract Research in Promenadenweg 10 Clinical Pharmacology and Biopharmaceutical Analytics GmbH GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) Area of Expertise 9 (quantitative proof of specific DNA or RNA sequences (DNA/RNA sequencing) for safety testing of pharmaceuticals) 9 (biomedical invasive, noninvasive, radiodiagnostic procedures and histopathology of large and small animals) 2-6-8 3 8 page 9/14 List of GLP Test Facilities / Test Sites Test Facility / Test Site Landesanstalt für Landwirtschaft, Forsten und Gartenbau (LLFG) Sachsen-Anhalt Landwirtschaftliche Untersuchungs- und Forschungsanstalt (LUFA) Address 06406 Bernburg Strenzfelder Allee 22 Area of Expertise 6 (field part) 67346 Speyer Obere Langgasse 40 6-8-9 (determination of soil parameter) Landwirtschaftliches Technologiezentrum (LTZ) Augustenberg Abteilung 2 76227 Karlsruhe Neßlerstraße 23-31 6 Landwirtschaftskammer Nordrhein-Westfalen Pflanzenschutzdienst 53229 Bonn Siebengebirgsstraße 200 6 LAUS GmbH 67489 Kirrweiler Auf der Schafweide 2 LPT Laboratory of Pharmacology and Toxicology GmbH & Co.KG 21147 Hamburg Redderweg 8 1-3-4-5-6-8-9 (toxicological in vitro studies on mammalian cells and bacteria) 2-3-4-9 (safety pharmacology; contract archive) Madaus GmbH Prüfstandort/ test site: Archiv 51067 Köln Colonia-Allee 15 9 (archive) Medical Device Services Dr. Rossberger GmbH 82205 Gilching Lilienthalstraße 4 Menal GmbH 79312 Emmendingen Im Hausgrün 15 3-9 (cytotoxicity and hemolysis testing by biological test systems) 8 Merck KGaA Institute of Drug Metabolism and Pharmacokinetics 85567 Grafing Am Feld 32 2-9 (pharmaco-/toxicokinetics and metabolism, accompanying analytics for pharmacokinetic and toxicological examinations) Merck KGaA Darmstadt Merck Serono Non-Clinical Safety 64293 Darmstadt Frankfurter Straße 250 2-3-4-9 (safety pharmacological studies) Merz Pharmaceuticals GmbH Biologische Analytik 60438 Frankfurt/Main Alfred-Wegener-Straße 2 1-8 MFD-Diagnostics GmbH 55234 Wendelsheim Microforum Ring 5 2 Microcoat Biotechnology GmbH 82347 Bernried Am Neuland 3 8 GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) page 10/14 List of GLP Test Facilities / Test Sites Test Facility / Test Site MICROMUN Privates Institut für Mikrobiologische Forschung GmbH Address 17489 Greifswald Walther-RathenauStraße 49a MLM Medical Labs GmbH 41066 Mönchengladbach 8 Dohrweg 63 MSD Animal Health Innovation GmbH Forschung und Entwicklung Tiergesundheit (FTG) 55270 Schwabenheim Zur Probstei 2-5-6-9 (sensibility testing on bacteria; palatability testing) NMI Technologietransfer GmbH 72770 Reutlingen Markwiesenstraße 55 9 (hErg Patch Clamp studies according to ICH S 7b) Nuvisan GmbH Bioanalytik – Pharmazeutische Analytik 89231 Neu-Ulm Wegenerstraße 13 8-9 (chromatographical analysis of formulations for toxicological studies; toxicokinetics) Octapharma Biopharmaceuticals GmbH Abteilung Virus- und Prionenvalidierung 60438 Frankfurt/Main 9 (virus validation studies) c/o Frankfurter Innovationszentrum Biotechnologie (FIZ) - Altenhöferallee 3 12347 Berlin 6 (field trials) Mohriner Allee 137 Pflanzenschutzamt Berlin Area of Expertise 2-9 (virus clearance studies) Pharmacelsus GmbH 66123 Saarbrücken Science Park 2 PRIMACYT Cell Culture Technology GmbH 19061 Schwerin Hagenower Straße 73 Prolytic GmbH 60386 Frankfurt/Main Alt Fechenheim 34 89081 Ulm Helmholtzstraße 22 Science Park I 35578 Wetzlar Schanzenfeldstraße 8 1-8 Rhein Biotech GmbH [Dynavax Europe] 40595 Düsseldorf Eichsfelder Straße 11 Rheinland-Pfalz (RLP) AgroScience GmbH 67435 Neustadt an der Weinstraße Breitenweg 71 8-9 (analysis of proteins/ accompanying substances in products/ biological materials; characterisation of cell banks; analysis of humoral/cellular immune responses) 4-5-6 PTRL Europe GmbH Regierungspräsidium Gießen Pflanzenschutzdienst Hessen – Dezernat 51.4 GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) 2-8-9 (pharmacodynamic, pharmacokinetic, metabolical and toxicological testing) 9 (toxicity/metabolism testing on human/animal cell cultures) 1-5-6-8 6 page 11/14 List of GLP Test Facilities / Test Sites Test Facility/ Test Site Rhenus Office Systems GmbH Prüfstandort/ test site: Auftragsarchiv Address 59439 Holzwickede Rhenus-Platz 1 (head quarter, IT) and 4 archive sites: 51375 Leverkusen, Hornpottweg 9 60314 Frankfurt/M., Schmickstraße 14 14979 Großbeeren, Märkische Allee 1-11 80999 München, Elly Staegmeyr-Str. 2 69493 Hirschberg Goldbeckstraße 13 Area of Expertise 9 (GLP contract archive) SakostaCAU GmbH Prüfstandort/ test site 63303 Dreieich Im Steingrund 2 9 (closed archive) Sanofi-Aventis Deutschland GmbH R&D – SCP Disposition, Safety & Animal Research (DSAR) Operational Center Frankfurt 65926 Frankfurt/Main 2-3-8-9 (bioanalytics for biologiIndustriepark Höchst cals) Gebäude G875, G879u.a. RIFCON GmbH 4-7 SCC Scientific Consulting Company 55545 Bad Kreuznach Chemisch-Wissenschaftliche Am Grenzgraben 11 Beratung GmbH Prüfstandort/ test site: Auftragsarchiv 9 (contract archive) SGS Institut Fresenius GmbH Product Development – Regulatory Testing Services 65232 Taunusstein Im Maisel 14 1-4-5-6-9 (in vitro toxicological tests) Siemens AG – Prozess-Sicherheit PD PA AE ECProcess Safety & Lab 65926 Frankfurt/Main Industriepark Hoechst Gebäude B 596/598 1-5 Spectral Service AG 50996 Köln 1 Emil-Hoffmann-Straße 33 Spiess-Urania Chemicals GmbH Forschung & Entwicklung Prüfstandort/ test site 25593 Christinenthal Loofter Straße 9 9 (archiving and storage of documents and materials) Staphyt GmbH 74572 Blaufelden Langenburger Straße 35 4-5-6 Steinbeis-Transferzentrum Angewandte und Umwelt-Chemie an der Hochschule Reutlingen 72762 Reutlingen Alteburgstraße 150 4-5 GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) page 12/14 List of GLP Test Facilities / Test Sites Test Facility / Test Site Thor GmbH Address 67329 Speyer Landwehrstraße 1 Area of Expertise 1-5 Thüringer Landesanstalt für Landwirtschaft Abt. Untersuchungswesen 07743 Jena Naumburger Straße 98 8 tier3 solutions GmbH 51381 Leverkusen Kolberger Straße 61-63 4 TPL Pathology Labs R & D 79111 Freiburg Sasbacherstraße 10 Trifolio-M GmbH 35633 Lahnau Dr.-Hans-WilhelmiWeg 1 9 (preparation of animal tissue specimens and cells as well as histopathological examination [including immunohistology and cutting-grinding technique]) 8 UKT Universitätsklinikum 72076 Tübingen Tübingen Calwer Straße 7/1 Klinik für Thorax-, Herz- und Gefäßchirurgie Klinisches Forschungslabor 9 (hemocompatibility tests of medical devices according to DIN EN ISO 10993-4) UL International GmbH Standort UL MDT 88416 Ochsenhausen Grenzenstraße 13 Umweltbundesamt (UBA) Ökotoxikologielabor 12307 Berlin Schichauweg 58 9 (biological, chemical, physical, physico-mechanical and comparative testing of medical devices; microbiological testing of medical devices including disinfectants, cleaning and sterilization procedures) 4 Universität Rostock Universitätsmedizin Rostock Institut für Biomedizinische Technik Universitätsklinikum Freiburg Department für Zahn-, Mund- und Kieferheilkunde Abteilung für Orale Biotechnologie 18119 Rostock Friedrich-BarnewitzStraße 4 2-9 (evaluation of haemocompatibility & cytotoxicity, endotoxin assay) 79106 Freiburg Hugstetter Straße 55 9 (cell culture-based cytotoxicity and biocompatibility investigations in vitro) GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) page 13/14 List of GLP Test Facilities / Test Sites Test Facility/ Test Site Universitätsmedizin Greifswald Institut für Pharmakologie Address 17487 Greifswald Felix-Hausdorff-Straße 3 Area of Expertise 9 (determination of drugs and/or metabolites in biological matrices) Versuchswesen Pflanzenschutz – Dr. Paul Reh 30938 Burgwedel Ehlbeek 2 6 (field trials) vivo Science GmbH 48599 Gronau Fabrikstraße 3 2-9 (immuntoxicology / immunogenicity in vitro/in vivo) Wilex AG 81675 München Grillparzerstraße 10 8-9 (HPLC determination of substances in vehicles of test items) Z.A.S. Zentral Archiv Service GmbH 17033 Neubrandenburg Prüfstandort/ test site: AuftragsarJustus-von-Liebigchiv Straße 7 9 (archiving) Zwisler Laboratorium GmbH 8-9 (toxicological properties in vitro; studies to determine microbial, cellular and toxicological contaminations) 78462 Konstanz Blarerstraße 56 Test Facilities in other countries certified by the German GLP Federal Bureau Test Facility Jiangsu Sinography Testing Co. Ltd. (JSST) Address 6F Rencai Building, 10# Xinghuo Road Pukou High-Tech Zone Nanjing, Jiangsu Province P.C. 210061 P. R. CHINA Rotam Research Laboratory (RRL) No. 90 Xingang West Road 1-4 Chengxiang Town Taicang City Jiangsu Province 215 414 CHINA Scientific Center for Antiinfectious Drugs (SCAID) 75, Al Farabi Ave 1-3 (in vitro) Academy Campus 60 Almaty 050060 Republic of KAZAKHSTAN GLP Federal Bureau: List of GLP Test Facilities/Test Sites, Germany (2015-05-29) Area of Expertise 1-8 page 14/14
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