Fully Compliant with US FDA, OECD, Chinese SFDA GLP Requirements
WuXi AppTec provides a full range of in vivo and in vitro preclinical safety evaluation studies which are part of our integrated portfolio of drug discovery and development services.
By focusing on quality, scientific expertise, flexibility and responsiveness, WuXi partners with our Sponsors to provide a wide range of IND/NDA enabling toxicology and laboratory services that meet global regulatory standards.
Our services are designed to help our worldwide customers shorten the time and lower the cost of Research and Development through cost effective and efficient outsourcing solutions.
Compliance and Accreditations:
- WuXi has worked with scientists and government authorities to establish services that meet international regulatory requirements.
- AAALAC accredited facility
- OECD – received a statement of GLP compliance from Belgium regulatory authorities
- China SFDA – received certificate of GLP compliance
- Bioanalytical - bioequivalency inspection conducted by US FDA
- WuXi has conducted IND and NDA enabling studies for submission to the US FDA, EMA and other global Regulatory Authorities.
- General Toxicology (acute, sub-chronic, chronic, carcinogenicity)
- Developmental and Reproductive Toxicology
- Genetic Toxicology (screening and regulatory assays)
- Safety Pharmacology
- Anatomic and Clinical Pathology
- Analytical Chemistry
- Bio-analysis; TK modeling
WuXi AppTec's Early Diagnosis Test (EDT) Program
Reduce the risks and costs of pre-clinical safety evaluation through early detection of drug candidates with toxic potential by using our established testing packages.