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