• Design and implementation of time and cost effective nonclinical strategies which are fully compliant with ICH guidelines
    • A primary objective is the avoidance the needless repetition of studies
  • An integrated analysis of nonclinical data (pharmacology, DMPK and toxicology) to identify gaps and issues which could impact progression of a drug candidate in the clinic and/or the marketing and post-marketing phases of development
    • Based on a gap-analysis of the integrated data package, preparation of a risk management strategy to resolve nonclinical issues
    • Deployment and follow-up of cost and time effective risk management strategies