Global Regulatory Affairs & CMC Submission Support

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WuXi STA's dedicated Global Regulatory Affairs CMC teams offers comprehensive CMC documentation support for IND, CTA, MAA, and NDA applications in western countries and China. Our highly experienced team works with your NCE programs to prepare Module 2 and Module 3 of your regulatory dossier through forecasted gap analyses and meticulous preparation of source documents. This can add tremendous value to your development program, dramatically expediting your speed to market. Services Include: - CMC Dosser Preparation & Technical Review for USA, Europe, and China - Strategy, Planning, & Feasibility Consultation - Regulatory Contribution Guidance - Gap Analyses & Support Services - Document Translation Services
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Biopharmaceutical ProductsContract Development and Manufacturing Organisations (CDMOs) and Contract Manufacturing Organisations (CMOs)Regulatory AffairsChemistry, Manufacturing and Controls (CMC)ProductsServices
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Biopharmaceutical ProductsContract Development and Manufacturing Organisations (CDMOs) and Contract Manufacturing Organisations (CMOs)
WuXi STAWuXi STA, part of WuXi AppTec, with locations across North America, Europe and Asia, provides industry-leading pharmaceutical development and manufacturing services to the life sciences industry. As an innovative Contract Development and Manufacturing Organization (CDMO) for small molecule drug development, WuXi STA enables our partners to achieve their goals through efficient, flexible, and high-quality solutions from preclinical to commercial uses.

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