Analytical Services
Full Range of Analytical and Regulatory Services
WuXi Biology and Testing’s Analytical Service Unit supports clients from preclinical phases through market supply. Our flexible analytical solutions are available as part of an IND- or NDA-enabling package, as well as on a standalone basis.
As part of our integrated approach, the Analytical Service Unit works in close collaboration with the DMPK, Bioanalytical, and Toxicology units, allowing our highly skilled teams to leverage their complementary capabilities to deliver the highest-quality data with speed and efficiency.
Quality Analytical Services
Our analytical programs include API and drug product method development, validation and release; manufacturing support; IND and NDA enabling stability studies; reference standard qualification; impurity control; preformulation; and product characterization.
Our technical writers provide regulatory support by composing IND and NDA packages, and have a proven record of successfully submitting these packages to global regulatory agencies. Our commitment to world-class quality has been validated by government agencies as well as numerous clients, and we adhere to strict program and process management standards for all studies.
- Early & Late Phase Analytical Development
- Stability Studies
- Impurity Research
- Highly Potent Compound Analysis
- Large Molecule Analysis
- Microbial Testing
- Preformulation Study
- Physicochemical Characterization & Excipient Release
Dedicated Facility
Based in Shanghai, China, the Analytical Service Unit has 8,500 square meters of laboratory space, with a capacity of approximately 1,000 cubic meters of available chamber storage. The facility houses state-of-the-art instruments to support analytical development and stability studies for both small and large molecule products.
Track Record of Success
From method development and validation to NDA preparation and submission, the Analytical Service Unit is your single solution for analytical development and regulatory support, having conducted stability programs for more than 2,000 API and drug product batches and prepared more than 50 CMC dossiers to date.
Analytical Service Unit Performance
Customers for Discovery Chemistry & Separation, API & Clinical Trial Material Manufacturing
INDs / NDAs Submitted to FDA
Stability Programs Conducted for 1K Batches of API & Drug Products
CTDs / CTAs Submitted to CFDA
Operations and Compliance
Our Analytical Services Unit operates in full compliance with FDA, MPA, CFDA, and GMP requirements, as validated through regular inspections by both regulatory authorities and our clients. Each of our employees undergoes a systematic training regimen that covers analytical sciences, GMP compliance, workflow operations and standard operating procedures to ensure our quality standards are consistently being met across the division.
- 220+ GMP Client-Initiated Audits Since 2009
- Numerous CFDA Inspections
- Electronic Data Handling Compliant with FDA 21 CFR Part 11
- Periodic Inspections & Data Completeness Review from Independent QAU
- Highly Capable Team of 400+ Staff Across Analytical Development, and Stability
Explore Solutions for Your Program
Explore solutions by development phase, drug modality, therapeutic area, or integrated discovery needs.
You May Also Be Interested In
Get a Quote
Ready to plan your next study? Share your program needs with our team for a tailored estimate.