"Paracelsus has been an indispensable member of this team since 2007 and is responsible for providing strategic and operational nonclinical safety support to TD2 client programs... "
TGen Drug Development
Stephen Gately, PhD

Professional Nonclinical Services

(Pharmacology, Pharmacokinetics, Toxicology)

  • Strategic integrated nonclinical development plans
  • Nonclinical program design, protocol development/finalization and study execution
  • Bid solicitation and Contract Research Organization (CRO) selection for exploratory (nonGLP-compliant) and definitive (GLP-compliant) nonclinical studies and programs
  • Critical evaluation of CRO competencies and facilities
  • Monitoring of outsourced nonclinical studies to ensure compliance to study protocol and CRO Standard Operating Procedures (SOPs)
  • Review and interpretation of nonclinical data
  • Preparation and review of nonclinical assessments, reports, summaries and presentations
  • Clinical starting dose selection based on nonclinical safety data
  • Review and integration of the scientific literature
  • Preparation of high-quality, submission-ready nonclinical summary documents (IND/CTA, NDA/BLA, etc.)
  • Project Team subject matter expertise
  • Preparation for and subject matter expert representation during due diligence activities
  • Scientific Advisory Board membership