Nonclinical Development

Nonclinical development supports the generation and interpretation of preclinical data required to advance products into and through clinical development. These activities inform regulatory strategy, dose selection, and risk assessment prior to human exposure.

Nonclinical programs typically integrate pharmacology, toxicology, and safety assessments aligned with regulatory expectations. Early alignment between nonclinical plans and clinical development strategy helps reduce delays and avoid unnecessary studies.

Well-designed nonclinical development supports efficient progression into IND-enabling and later-stage programs.

Nonclinical development activities commonly include:

• Nonclinical strategy and study planning

• IND-enabling nonclinical program support

• Interpretation of toxicology and safety data

• Alignment with clinical and regulatory plans

• Regulatory documentation support related to nonclinical data