Optimizing nonclinical development can help maximize the likelihood of success in clinical development. RPI’s nonclinical safety experts have extensive experience working for the FDA and industry. We consult on pharmacology, drug metabolism and pharmacokinetics, and toxicology matters, including the strategic design and management of nonclinical studies related to investigational new drugs, new drug applications, and biologics license applications.
- Toxicology study planning
- Planning of ancillary toxicology studies supporting chemistry, manufacturing, and controls
- Service provider selection
- Nonclinical and clinical program integration