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- tdsteele@outlook.com
Nonclinical Safety Solutions (NCSS) provides senior-level toxicology consulting designed to support pharmaceutical and biotech teams through the scientific, strategic, and regulatory challenges of modern drug development. With more than 25 years of combined industry and FDA experience, Dr. Thomas D. Steele delivers high-value scientific insight, rapid issue identification, and clear strategic guidance across the full spectrum of nonclinical safety evaluation.
Drug developers rely on NCSS when they need rigor, clarity, and confidence in their safety strategy. Whether preparing your first IND, troubleshooting unexpected findings, designing GLP and non-GLP study programs, or determining a defensible path to human dosing, NCSS provides the expertise necessary to accelerate development and support regulatory success.
NCSS was founded to fill a critical gap in the industry: access to reliable, senior-level toxicology leadership tailored to each program’s unique challenges. Many teams struggle with fragmented advice or inexperienced support. NCSS eliminates that risk by offering pragmatic, scientifically defensible toxicology guidance grounded in decades of real-world experience and successful agency interactions.
A strong toxicology strategy is one of the most important predictors of regulatory success. Missteps in study design, data interpretation, or study sequencing can delay development, trigger FDA questions, or jeopardize first-in-human approvals. NCSS brings clarity, foresight, and scientific depth to prevent these pitfalls while ensuring every decision is well-justified, defensible, and aligned with regulatory expectations.
With extensive experience spanning oncology, neurosciences, inflammation, metabolic disease, virology, imaging agents, biologics, small molecules, and emerging modalities, NCSS offers the rare combination of scientific depth and regulatory insight that modern development teams require. If you’d like expert support for your program or have questions about how these services apply to your development strategy, request a consultation and NCSS will review your needs and provide clear, science-driven guidance.
A toxicology consultant designs nonclinical programs, interprets data, identifies safety risks, and guides teams toward strategies that support IND submissions and clinical progression.
Ideally during discovery or lead optimization, ensuring studies are efficiently designed and aligned with regulatory expectations before key development decisions.
Requirements vary by molecule, but typically include repeat-dose toxicology, safety pharmacology, genetic toxicology, PK/ADME assessments, and species-selection justification.
Yes. NCSS specializes in evaluating adverse or ambiguous findings, determining relevance, and recommending follow-up strategies to keep development on track.
NCSS assists with briefing documents, safety arguments, written responses, meeting preparation, and data presentation to streamline regulatory interactions.
Experience spans oncology, CNS, metabolic disease, immunology, virology, imaging agents, biologics, small molecules, and a wide range of emerging therapeutic modalities.