Updated on 12 October 2026
Integrated CMC development for DS and DP with accelerated timelines
Business Development Director, Europe at WuXi AppTec
Gräfelfing, Germany
About
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CMC competency: 1.000+ CMC submission packages written to support global IND and NDA filings during 2019-2026
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Speed: With our integrated CRDMO model we can deliver entire IND enabling package, including DMPK/Tox and CMC dossier typically within 7-8 months, for complex small molecules and TIDES within approx. 10 months.
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EU batch release: With our own QP based in our European Headquarter in Munich-Gräfelfing we can manage EU Batch release for clinical and commercial supply.
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Reliable development timelines in late stage: 180+ NCE PPQ (Process Performance Qualification) completed 2018-2025 with 100% success rate & rich track record supporting first time US FDA and EMA approvals
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Global manufacturing network:
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US: We will become operative with our new drug product site in Middletown, Delaware (US) for OSD in q4 this year and for injectables in q4/2027.
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CH: We added PSD-4 (GEA) SSD capabilities in our EMA, US FDA / Health CA and JP GMP approved OSD site in Couvet, Switzerland becoming operative in October this year
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SG: We will have our GMP manufacturing site operative in January 2027
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Organisation
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