NDA-Enabling and Clinical Development
Comprehensive Clinical Development Support
Support your New Drug Application (NDA) with GLP safety assessment and bioanalytical testing services from WuXi Biology and Testing. We provide a fully integrated program that addresses the complex reporting needs of your candidate.
NDA-Enabling Testing by The Numbers
NDA-Enabling Packages
Safety Assessment Studies Since 2011
On-Time Data & Report Delivery
Your Path from Phase I to Phase III to New Drug Application
We combine world-class drug development testing with expert bioanalytical capabilities, program management, and regulatory expertise to move your candidate through Phase I, Phase II, and Phase III studies in support of your NDA submission.
General Toxicology
Phase II and III clinical trials have additional safety assessment requirements, including longer-duration studies. Subchronic and chronic toxicology studies evaluate safety, dosage, efficacy, and side effects to support your clinical plan. We offer 13-, 26-, and 39-week toxicity (rodent and non-rodent) tests and related data reporting for long-term studies.
Specialty Toxicology
Depending on the patient population and indication, certain specialty toxicology studies must be completed. We offer:
- Developmental and Reproductive Toxicology testing (Segment I-III)
- Carcinogenicity testing (2-year (rat), 2-year (mouse), or 6-month (transgenic mouse))
- Other specialty tests, including Juvenile Tox (if applicable) and 4-week Batch Impurity Study (rat)
- AE investigative-type studies
Regulatory Affairs
Make global filings convenient, efficient, and cost-effective across the regulatory agencies with our regulatory submission support.
- Gap analysis
- Contractual assistance
- Business unit coordination
- Program updates and teleconferences
Clinical Bioanalytical Solutions
We provide study support for small and large molecule and innovator drugs.
- LC-MS/MS and Ligand Binding platforms
- Clinical PK sample analysis
- Radiolabeled hAME sample analysis and study support
- Clinical metabolite ID and (radio) profiling: 3H and 14C
- MIST cross-species metabolite comparison
- 14C-labeled and 19F-NMR mass balance
- Soluble, genetic, cellular, and tissue biomarker analysis
End-to-End Program Management
Our dedicated program management (PM) team supports your drug candidate from discovery to preclinical to clinical stages, including design, timeline determinations, study execution, progress tracking, issue resolution, dossier preparation, and regulatory submission.
Global Partner and Network
We advance small and large molecules from preclinical through IND, NDA, and commercialization with state-of-the-art facilities across the US, Europe, and China:
- First cGMP biologics facility compliant with US, EU, and NMPA standards
- First GLP preclinical lab in China OECD/NMPA certified and US inspected
- First GLP/GCP bioanalytical lab in China passing US, OECD, and NMPA inspections
End-to-End Global Regulatory Support
We streamline global filings across international health authorities with an efficient, cost-effective, one-stop regulatory approach:
- Strategic Planning and Consultation: Regulatory strategy, product registration planning, and program feasibility assessments.
- Dossier Development and Gap Analysis: Comprehensive gap analysis based on existing dossier information and full dossier composition.
- Agency Interactions and Submissions: eCTD electronic submissions, annual reporting, post-approval supplements, and direct communication meetings with regulatory agencies.
- Inspection and Testing Coordination: On-site regulatory inspection coordination and progress tracking for NIFDC testing in China.
- Lifecycle Maintenance: Complete support for product registration maintenance and post-submission requirements.
Related Services
We combine world-class laboratory testing with expert bioanalytical capabilities, program management, and regulatory insights to move your candidate through Phase I, II, and III studies. Explore our four core service categories supporting your NDA path.
Discovery Biology
End-to-end program management and global regulatory support from early discovery through dossier preparation.
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DMPK
Advance your clinical program with integrated PK sample analysis, radiolabeled hAME studies, and multi-platform biomarker testing.
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Bioanalysis
Validate candidate safety and efficacy using high-sensitivity LC-MS/MS assays and biomarker panels.
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Safety Assessment
Mitigate candidate safety risks through integrated chronic toxicity, carcinogenicity, and specialized toxicology evaluations.
Learn More
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Discuss Your Program with Us
Share your development goals and key challenges with our experts to define the right path forward.
Frequently Asked Questions
NDA-enabling testing involves a series of studies conducted to support a New Drug Application submission to regulatory agencies. These tests are essential to demonstrate the safety, efficacy, and quality of a new drug before it can be approved for market.
NDA-enabling testing is necessary for the development of new drugs because it provides comprehensive and longer-term data on the drug’s performance, safety profile, and therapeutic effectiveness. This information is crucial for regulatory bodies to assess whether the drug meets the required standards for approval.
NDA-enabling testing differs from other stages of drug development as it focuses on gathering final data needed for regulatory approval, rather than early-stage discovery or preliminary safety evaluations. It encompasses a broader and more detailed assessment compared to earlier stages.
NDA-enabling testing typically takes several years to complete, depending on the complexity of the drug and the scope of the required studies. This timeline includes conducting the studies, analyzing the data, and preparing the necessary documentation for the NDA submission.
NDA-enabling tests are completed after an Investigational New Drug (IND) application is approved and phase I (First-In-Human) studies begin. They should be conducted throughout Phase I, II, and III studies to prepare for NDA submission.
Key considerations when selecting a partner for NDA-enabling testing include the partner’s expertise, experience, regulatory knowledge, and ability to conduct comprehensive and high-quality studies. Choosing the right partner is crucial for ensuring the success of the NDA-enabling phase. The data generated at this stage is complex, and the studies are long and expensive. Make sure you select a partner that has a proven track record, a team of experts, and can work with you in the long term.
Potential challenges associated with NDA-enabling testing include lengthy timelines, high costs, regulatory complexities, and the need for robust data management. These challenges require careful planning and management to ensure successful completion.
NDA-enabling testing helps mitigate risks associated with clinical trials by providing thorough safety and efficacy data, identifying potential adverse effects, and ensuring that the drug meets regulatory standards. This testing phase is crucial for minimizing risks before the drug reaches the market.