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Expert IND-enabling studies for drug development

Get a comprehensive preclinical testing program that prepares and supports your molecule or new modality through IND-enabling studies and application submission. We provide fully integrated programs that address the bioanalytical, DMPK, and toxicology testing needs of your candidate and meet the demands of your IND submission timeline. 

Tell us more about your compound by filling out the form on the right and one of our experts will be in touch

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

Advance your candidate further, faster

We combine world-class drug development testing with cross-functional program management and global regulatory expertise to shepherd your candidate through IND submission—saving you significant time and expense.

Bioanalysis

Put your molecule or new modality on the right track with a bioanalytical strategy designed to establish and execute the right assays for regulatory submission.

DMPK

Leverage a global network of facilities offering a full range of discovery screening, preclinical development, and clinical drug metabolism and pharmacokinetic services.

Toxicology

Our integrated safety assessment services provide multidisciplinary expertise and experience that saves time and cost while yielding the valuable data you need.

Pharmacology

Get validated discovery assays, including in vitro assays and in vivo disease models in cardiovascular, CNS, respiratory, metabolic, and infectious diseases.

CMC

We support your CMC authoring needs, in both the US and China, from preclinical to commercial lifecycle management for both drug substance and product. 

Regulatory Affairs

Make global filings convenient, efficient, and cost-effective across US FDA, NMPA, and EMA with our extensive regulatory submission support. 

Your end-to-end preclinical testing partner

With capabilities in safety assessment, DMPK/ADME, bioanalytical, pharmacology, Chemistry, Manufacturing and Controls (CMC) and analytical services all under one roof, WuXi AppTec is a global expert in preclinical development testing and can support the full scope of your development program, from discovery to IND-enabling studies to NDA submission.