Preclinical Development
IND Enabling Packages
NDA Enabling Packages
Molecules Evaluated in Pre-Formulation Studies
Safety Assessment Studies since 2011
in vivo Studies per Year
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.
Program Management
Bioanalysis & Regeant Generation
- LC-MS/MS & Immunochemistry platform
- Method development, transaction and validation
- Pre-clinical sample analysis (TK, PK)
- High throughput sample analysis (ADME, in-vitro, discovery)
- Biomarker testing
- Customized antibody service
Pharmacology
- In vitro assays
- In vivo efficacy in disease models
- Mechanism of action and translational medicine
CMC
- Process development
- GMP API manufacturing
- Pre-formulation
- Formulation development
- Small scale manufacturing
- Method development & validation
- Compound characterization & batch release
- Stability study
- Regulatory CMC
DMPK
- Permeability
- Metabolic stability
- Plasma protein binding
- RBC partitioning
- DDIM/ HI/ PNT
- Transporter profiling
- PK/bioavailability
- Met ID (in vitro/in vivo)
- Mass balance and tissue distribution (QWBA)
- PBPK, PK/PD assessment
- Human PK projection
Toxicology
- General toxicology
- Safety pharmacology
- Genetic toxicology
- Immunogenicity
- Biomarker analysis
- Bioanalysis (GLP)
- Toxicokinetics assessment
- Developmental and reproductive toxicology (DART)
- Clinical pathology and anatomic pathology
Dossier Prep & Regulatory Affairs
- IND feasibility evaluation
- Gap analysis
- Contractual assistance
- Business units coordination
- Project updates and teleconferences
Cross Functional Program Management
Accelerated Timeline
to expedite your molecule to IND
Dual Filing
in U.S. and China to increase asset value
Truly Integrated Platform
consolidating everything done within one organization
Flexible Collaboration
ranging from a la carte to IND package
High Quality
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.
Regulatory Expertise
WuXi AppTec’s regulatory team provides 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 filing convenient, efficient and cost-effective across the U.S. Food and Drug Administration (FDA), National Medical Products Administration (NMPA), European Medicines Agency (EMA), and beyond.
- 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
Global Partner & Network
WuXi AppTec is a truly global provider of preclinical small and large molecule solutions, with state-of-the-art facilities and experts across the US, Europe and China. We have decades of experience operating within diverse regulatory environments and delivering tailored testing solutions that advance small and large molecules from preclinical through IND, NDA and beyond.
- 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