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Preclinical Development

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IND-Enabling Testing Platform

WuXi AppTec’s preclinical testing platform combines world-class 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. For further details, please see our services section.

WuXi IND (WIND)

Integrated Services for Your IND Packages
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.

Comprehensive IND Enabling Services

WuXi AppTec’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.

Global Compliance

  • 1st CMC platform in China which passed U.S. FDA inspection for new chemical entities
  • 1st cGMP biologics manufacturing facility in China compliant with U.S., European and Chinese regulatory standards
  • 1st GLP preclinical laboratory in China double certified with an OECD country and NMPA (CFDA); passed U.S. FDA inspection
  • 1st GLP/GCP bioanalytical lab in China which passed U.S. FDA, OECD, and NMPA (CFDA) inspections

Program Management

The program management (PM) team will provide a full service project manager that support IND program design, study execution to dossier preparation and submission. The PM team provides information and consultation for clients during initial project discussion with our Business Development team.

PMs will help clients design programs based on global submission requirements, establish project timelines for initiation and completion of required studies and help track the progress of ongoing activities. They coordinate with technical groups and scientific experts to help resolve any issues that may occur during on-going studies. Along with the regulatory affairs group, the PMs will help you prepare the dossier and design your submission plan.

Regulatory Affairs

WuXi AppTec’s regulatory team provides you a complete package of services to support global regulatory submission by incorporating internal expertise and partnering with external consultation networks. Our one-stop service can make your global filling convenient, efficient and cost-effective across U.S. FDA, NMPA and European Medicines Agency (EMA).

We can assist you in the following aspects:

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