Preclinical Toxicology Programs

  • Development and management of full preclinical toxicology programs
  • Identification of CROs for preclinical studies, review of protocols and reports, study monitoring
  • Preparation of regulatory documents (IND, CTD submissions, briefing documents, updates)
  • Participation in FDA meetings
  • In-licensing due diligence reviews
  • Interpretation and resolution of preclinical toxicity issues
  • Research and preparation of white papers

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Preclinical Pathology and Research

  • Attendance and monitoring of necropsy
  • Primary and peer review histopathology evaluation of GLP and non-GLP studies
  • Design of research projects for problem resolution
  • Utilization and interpretation of immunocytochemistry and electron microscopy techniques
  • Interpretation of studies using genetically altered animal models