Late-stage nonclinical
Optimize your nonclinical programs to support successful NDA/BLA submissions
Crucial nonclinical studies run concurrently with clinical trials, providing essential data to support New Drug Application (NDA) or Biologics License Application (BLA) submissions. The data produced during continued safety, pharmacokinetic, pharmacodynamic, and mechanistic assessments support ongoing clinical development and optimize dosing, while addressing emerging risks and refining understanding of the drug’s effects.
Build a comprehensive safety profile and address specific regulatory requirements
Labcorp's advanced facilities, technologies and expertise in nonclinical studies provide a competitive edge in navigating this critical stage of drug development. We enable you to optimize your nonclinical program to support successful NDA/BLA submissions while managing costs and timelines.
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Meet development milestones with our global capabilities and experienced team
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Minimize the risk of delays with trusted regulatory guidance
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Improve study outcomes with our state-of-the-art European animal housing and innovative animal welfare AI system
Explore our capabilities
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Chronic
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Radiolabeled ADME
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Impurities qualification
Compassionate animal welfare – CARE
We are committed to ensuring the welfare of animals we work with in research. Our state-of-the-art European animal housing facilities and innovative animal welfare AI system help ensure quality, effective late-stage studies.
Your pathway to regulatory success
Streamline regulatory interactions, writing and submissions to expedite development.
- Regulatory scientific review and gap analysis
- Meeting support services
- FDA SPA support for carcinogenicity study protocols
- Writing services
