Preclinical development is the foundation on which an entire drug program is built. Data from this stage not only supports the first-in-human dose but also frames whether the therapy is considered safe enough to advance. Many teams struggle to decide which toxicology, pharmacology, and safety pharmacology studies are truly essential, how to design them so they withstand FDA review, and how to sequence them to avoid duplication, gaps, or delay. Missteps at this point can lead to wasted time, unnecessary spend, and avoidable regulatory risk. A strong preclinical program is an integrated package that answers core questions about mechanism, exposure, safety margins, and risk mitigation, all in the context of the target indication and label regulators will evaluate later.
HIC designs preclinical programs that connect scientific rigor with regulatory reality. Our nonclinical strategists and former FDA toxicology and pharmacology reviewers work with your team to align studies with the planned clinical strategy, select appropriate species and study designs, and define exposure margins that support proposed doses. Every study is planned with GLP expectations in mind, vendors are qualified, and reports are prepared to inspection ready standards. The result is a preclinical package that goes beyond minimum requirements, creates a solid scientific foundation for the IND, and positions your program for a smooth transition into clinical development.
Preclinical packages engineered for IND readiness
- Our team includes former FDA toxicology and pharmacology reviewers who bring direct insight into how nonclinical packages are evaluated in practice
- We design focused, efficient programs that avoid unnecessary studies while still meeting regulatory expectations for IND enabling safety
- Our experts provide vendor oversight and detailed quality review, so every report is consistent, traceable, and inspection ready
- We integrate preclinical strategy with the broader regulatory and clinical plan, so safety, dosing, and labeling assumptions stay aligned throughout development
