Global Facilities and Compliance
Headquartered in Shanghai, the Laboratory Testing Division has five Drug Development sites throughout China and the United States. Each facility operates in strict compliance with global regulatory requirements and maintains AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) accreditations for animal health and welfare where in vivo testing takes place.
Shanghai, China (Global Headquarters)
288 Fute Zhong Road
Waigaoqiao Free Trade Zone
Shanghai 200131)
China
Telephone
+86 (21) 5046-1111
Bioanalytical
- 71,000 square feet of laboratory space
- Data accepted by worldwide health authorities
- Non-GLP, GLP and Good Clinical Practice (GCP) bioanalysis for preclinical and clinical development
- Small and large molecule support
DMPK
- 40,000 square feet of laboratory space
- Full panel ADME/PK Discovery and Development studies
- Single studies and integrated programs
- Assay Automation, E-record Systems and electronic project management
- Specific Study Director and Program Management Expertise
- Seamless Integration with MedChem, Biology, Pharmacology within WuXi AppTec
Suzhou, China
1318 Wuzhong Avenue
Wuzhong District
Suzhou (P.C.215104)
China
Telephone
+86 (512) 6603 2632
Bioanalytical
- 87,200 square feet of laboratory space
- On-site support for all in vivoGLP Toxicology studies and Pharmacokinetics (PK) studies
- Small and large molecule support
- Integrated study flow from PK to Toxicology and Safety Pharmacology
- Bioreagent generation
DMPK
- 18,000 square feet of laboratory space
- Full Panel ADME/PK Discovery and Development studies
- Single Studies and Integrated Programs
- Assay Automation, E-record Systems and Electronic Project Management
- Specific Study Director and Program Management Expertise
Toxicology
- 580,000 square foot facility
- 600+ employees
- 220 study rooms
- HEPA-filtered, computer-controlled and monitored HVAC
- Double-barrier study rooms to meet Pharmaceutical and Medical Devices Agency (PMDA) and NMPA requirements
- State-of-the-art equipment and security
Nanjing, China
No.1 Hengfei Road
Economic & Technological Development Zone
Nanjing (P.C.210038)
China
Telephone
+86 (25) 6698 7059
DMPK
- 45,000 square foot facility
- 20+ years supporting IND/NDA submissions
- Pharmacokinetic and Radiolabel studies
- Metabolite Profiling & Identification
- Mass Balance & Bile Duct Cannulated studies (rodent and dog)
Cranbury, New Jersey, USA
6 Cedarbrook Dr.
Cranbury, NJ 08512
USA
Telephone
+1 (609) 799 2295
DMPK
- 54,600 square foot facility
- 30+ years of experience supporting discover, IND-enabling and late stage development
- In vitro ADME
- In vivo PK
- Biotransformation
- Mass Balance and Quantitative Whole-Body Autoradiography (QWBA),
- Translational PK/PD-biomarker analysis
Plainsboro, New Jersey, USA
107 Morgan Lane
Plainsboro, NJ 08536
USA
Telephone
+1 (609) 799 2295
Bioanalytical
- 45,000 square foot facility
- 30+ years of providing bioanalytical services
- Non-GLP, GLP and GCP bioanalysis for preclinical and clinical development
- Small and large molecule support
- Regularly inspected by U.S. FDA
- Yearly / biannual repeat site qualification for major innovator and generic pharma companies
- 100% of data accepted by clients and regulatory authorities
Chengdu, China
No.388 Haifa Road,
Chengdu Cross-Strait Science & Technology Industrial Development Park, Wenjiang District,
Chengdu, Sichuan,
611130, China
Telephone
+86 (28) 6951-8888
Toxicology
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108,000 ft², State-of-the-art facility
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107+ employees
-
37+ study rooms
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ETS 123 compliant
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HEPA-filtered, computer-controlled and monitored HVAC
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Water-treatment on site and backup electrical generators
-
State-of-the-art equipment and security
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Imaging Center
Nantong, China
699 Huashi Nan Road,
Qidong Economic Development Zone, Nantong, Jiangsu,
226299, China
Telephone
+86 (513) 8339-3066
Toxicology
- 280,000 ft², State-of-the-art facility
- 210+ employees
- 113 study rooms
- HEPA-filtered, computer-controlled and monitored HVAC
- Water-treatment on site and backup electrical generators
- Discovery, IND and NDA enabling,
- Post NDA Studies