Preclinical Development


Integrated Services for Your IND Packages
WuXi’s preclinical testing platform combines world-class CRO services with cross-functional program management and global regulatory expertise to support Investigational New Drug (IND) applications. With capabilities in toxicology, DMPK, pharmacology, CMC and analytical services all under one roof, the Laboratory Testing Division can support the full scope of your drug development programs, from IND-enabling studies to document preparation and submission.

IND-Enabling Testing Platform

As a fully integrated platform, the Laboratory Testing Division houses a complete spectrum of IND-enabling services, providing our clients with flexible development options that result in significant time and cost savings.

    * CDMO services provided by WuXi subsidiaries STA Pharmaceutical (small molecule) and WuXi Biologics (large molecule).

    Program Management

    With WuXi AppTec, our clients not only benefit from the scientific knowledge and experience of a world-renowned CRO, but also from customized, dedicated support across the full scope of each project. Our project managers work with clients from the initial consultation through IND submission and beyond, designing a tailored program that meets both global regulatory requirements and the individual needs of each client’s submission strategy.

    • IND feasibility evaluation
    • Gap analysis
    • Contractual assistance
    • Service unit coordination
    • Client communication for project updates

    Regulatory Affairs

    Leveraging internal expertise and strategic partnerships with external consultant networks, the regulatory team supports clients with IND, NDA and ANDA submissions to global regulatory bodies, including the National Medical Products Administration (NMPA) and US Food & Drug Administration (FDA). At WuXi AppTec, it is our goal to make your global filing convenient, efficient and cost effective.

    • Regulatory consultation
    • Project feasibility assessment
    • Product registration strategy and planning
    • Gap analysis
    • Dossier composition
    • Communication meetings with regional regulatory agencies
    • Electronic Common Technical Document (eCTD) Submission
    • Coordination of on-site inspection
    • National Institute for Food & Drug Control (NIFDC) testing progress follow-ups in China
    • Annual reports and subsequent supplement submissions
    • Other assistance in product registration