Preclinical Drug Development

Comprehensive IND-Enabling Testing Platform

WuXi Biology and Testing’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, safety pharmacology, and analytical services all under one roof, we can support the full scope of your drug development programs, from IND-enabling studies to document preparation and submission.

600+

IND-Enabling Packages

200+

NDA-Enabling Packages

2K+

Molecules Evaluated in Pre-Formulation Studies

4.5K+

Safety Assessment Studies Since 2011

15K+

In Vivo Studies Per Year

IND-Enabled Testing Platform at a Glance

Program Management

Bioanalysis & Regent 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

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

Pharmacology

In vitro assays
In vivo efficacy in disease models
Mechanism of action and translational medicine

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 and Regulatory Affairs

IND feasibility evaluation
Gap analysis
Contractual assistance
Business units coordination
Program updates and teleconferences

Cross Functional Program Management

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

PMs will help you design programs based on global submission requirements. They establish program 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.

Accelerated Timeline

We accelerate your timelines to expedite your molecule to IND.

Dual Filing

We file in both the U.S. and in China to increase asset value.

Truly Integrated Platform

With our integrated platform, we can consolidate everything within one organization.

Flexible Collaboration

We have the flexibility to collaborate on programs ranging from a la carte to an IND package.

High Quality

Our experienced expertise, paired with a state-of-the-art facility, ensure high-quality standards with global regulatory compliance.

Regulatory Expertise

Our 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, program 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 and Network

We are a truly global provider of preclinical small and large molecule solutions, with state-of-the-art facilities and experts across the U.S., 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.