Good Laboratory Practice (GLP) - Test Facilities / Test Sites in the

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)
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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
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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)
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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
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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)
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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)
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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)
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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
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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)
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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
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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)
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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)
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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
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