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Comprehensive IND-Enabling Testing Platform
WuXi AppTec’s preclinical testing platform combines world-class drug development services with cross-functional program management and global regulatory expertise to support Investigational New Drug (IND) applications. With capabilities in safety assessment, absorption, distribution, metabolism and excretion (ADME), Drug Metabolism and Pharmacokinetics (DMPK), Bioanalytical, pharmacology, Chemistry, Manufacturing and Controls (CMC) and analytical services all under one roof, WuXi AppTec 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.
Download our WuXi IND (WIND) Brochure
Integrated Services for Your IND Packages
As a fully integrated platform, WuXi AppTec offers a complete spectrum of IND-enabling services, providing our clients with flexible development options that result in significant time and cost savings.
IND Enabling Packages
NDA Enabling Packages
Molecules Evaluated in Pre-Formulation Studies
Safety Assessment Studies since 2011
in vivo Studies per Year
Bioanalysis & Regeant Generation
Dossier Prep & Regulatory Affairs
Cross Functional Program Management
to expedite your molecule to IND
in U.S. and China to increase asset value
Truly Integrated Platform
consolidating everything done within one organization
ranging from a la carte to IND package
experienced expertise and state-of-the-art facility to ensure standard with global regulatory compliance
The program management (PM) team will provide a full service project manager that supports IND program design, study execution to dossier preparation and submission. The PM team provides information and consultation during the initial project discussion with our Business Development team.
PMs will help you design programs based on global submission requirements. They establish project timelines for initiation and completion of required studies and help track the progress of your ongoing activities. They coordinate with technical groups and scientific experts to help resolve any issues that may occur during ongoing studies. Along with the regulatory affairs group, the PMs will help you prepare the dossier and design your submission plan.
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. Food and Drug Administration (FDA), National Medical Products Administration (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
- 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; passed U.S. FDA inspection
- 1st GLP/GCP bioanalytical laboratory in China which passed U.S. FDA, OECD and NMPA inspections