Nonclinical Development

Navigating the regulatory environment from target selection to regulatory filing can be time-consuming and costly. Many early-stage drug discovery teams, particularly in academic environments or small organizations, lack the experience required to develop a preclinical program that will allow them to file an IND while minimizing expenditures and time. We have significant experience successfully planning and monitoring IND-enabling and NDA-enabling pharmacology, pharmacokinetic and toxicology studies.

• Pharmacology Studies
• Toxicokinetic and Pharmacokinetic Studies
• Acute Toxicity Studies
• Repeated-Dose Toxicity Studies
• Estimation of the First Dose in Humans
• Local Tolerance Studies
• Genotoxicity Studies
• Carcinogenicity Studies
• Reproduction Toxicity Studies
• Immunotoxicity Studies
• Specialized animal models of disease