Analytical and Bio-analytical Services
Fully compliant with FDA and SFDA GLP requirements
US FDA Audit with no 483 observations
WuXi AppTec has an understanding of the unique expectations of Bioanalytical services. A dedicated and knowledgeable team is able to meet our clients need for accurate, high quality data analysis on tight budgets. Our platforms and protocols provide extensive GLP and non-GLP Bioanalytical services for both small and large molecules.
GLP Bioanalytical Services
- Method development and validation - LC/MS/MS, ligand binding assay
- High throughput sample analysis - LC/MS/MS, ligand binding assay
- PK/TK/PD analysis for pre-clinical and clinical samples
- Synthesis of reference standard and labeled internal standards - LC/MS/MS
- Immunogenicity - ligand binding assay and cell-based assay
- Generic drug BE studies – pilot and pivotal
Discovery Bioanalytical Services
- Rapid turnaround quantitative analysis; Integrated with DMPK services
- Metabolite Identification; profiling, structure elucidation, and synthesizing authentic reference standard Quality Standards
- FDA/SFDA GLP
- ICH/SFDA GCP
- FDA 21 CFR – Part 11 and Part 58
Click here for PDF with more information.