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Analytical Service Unit


Analytical Service Unit (ASU)

Analytical Solution Provider at FDA, MPA and CFDA Inspected Laboratories

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Inspected by the FDA, MPA and CFDA, WuXi's analytical service laboratories provide a full range of analytical services from discovery to commercial products. Our analytical services include method development and validation, analytical testing, product stability testing and storage, separation, structure elucidation, physicochemical characterization, natural products studies and regulatory CMC documentation. With state-of-the-art instruments and experienced scientific staffs, we ensure efficient, high-quality and cost-effective services to our partners.

Early-Phase Analytical Development
IND/CTA-enabling API and drug product analysis. ( Learn More)

Late-Phase Analytical Development
NDA/MAA/ANDA-enabling API and drug product analysis. (Learn More)

Stability Studies
Early-phase to late-phase stability studies for global regulatory submission. (Learn More)

Regulatory CMC
CMC dossiers prepared by a dedicated regulatory writing group. (Learn More)

Impurity Isolation and Identification
Isolation and identification of impurity/degradation products to support process optimization and regulatory filings. (Learn More)

Physicochemical Characterization & Other Services
Full compound characterization. (Learn More)