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What is a Nonclinical Gap Analysis & Why It Matters

A Nonclinical Gap Analysis is a critical step in early drug development. It involves reviewing completed nonclinical studies and data packages to identify missing studies, data gaps, or areas requiring additional evaluation to support regulatory submissions, most critically the Investigational New Drug (IND) Application.

A well-executed nonclinical gap analysis helps prevent delays or refusal to file in regulatory submissions, ensures your development program meets agency expectations, and strengthens the foundation for first-in-human studies. By identifying and addressing gaps early, you can prioritize needed studies efficiently and reduce the risk of investors not funding your programs.

Xyzagen’s Approach to Nonclinical Gap Analysis

This is what we do at Xyzagen. We specialize in drug development and have worked with small to mid-sized organizations that funded ‘just enough.’ We provide a red/yellow/green light approach to the Nonclinical Gap Analysis so you know the risk of delaying certain studies prior to IND submission, which then sets your program up for success. Our team leverages decades of experience across pharmacology, bioanalytical, DMPK, toxicology, and CMC testing to provide a comprehensive assessment of your program.

On a more expansive basis, we also integrate Model-Informed Drug Development (MIDD) and data-driven decision-making to recommend possible nonclinical studies to support dose justification in your Phase 1 study prior to IND. This MIDD approach can then carry on into your clinical Phase 1 trial and beyond.

Using our proprietary First-in-Rat®, First-in-Mouse®, and expert regulatory insight, we help clients generate useful data, mitigate risk, and align with agency expectations. Our experts work closely with your internal team ensuring your nonclinical strategy is optimized for efficiency and success.

What Our Nonclinical Gap Analysis Can Provide

Our Nonclinical Gap Analysis provides actionable insights to support regulatory submissions and streamline your development program, including:

Comprehensive review of nonclinical study design and data package
Identification of missing studies or analyses critical for regulatory submissions
Strategic planning to mitigate risk and optimize development timelines
Integration with MIDD approaches to inform study design and translational strategies
Alignment with regulatory expectations to strengthen IND submissions

Partner with Xyzagen

Let us help you identify and address nonclinical gaps so your program advances smoothly from discovery through first-in-human studies. Contact us today to learn how our Nonclinical Gap Analysis services can strengthen your development strategy.

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