+1 (888) 794-0077

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)
picture of wuxi office in cranbury new jersey

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
picture of wuxi office in plainsboro new jersey

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