Preclinical Development

Design and oversee GLP toxicology studies — single-dose, repeat-dose, genotoxicity, reproductive toxicity, carcinogenicity. Select species, dose levels, and study durations per ICH guidelines. Analyze pathology data and write toxicology summaries for regulatory submissions.

Develop the drug product formulation — selecting excipients, optimizing dissolution and bioavailability, scaling from lab to pilot to commercial manufacturing. Characterize the API (active pharmaceutical ingredient), establish specifications, and build the CMC section of regulatory filings.