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Professional Toxicology Services
"We have had the great pleasure to work with Grace at Paracelsus on ENDECE’s lead oncolytic candidate, NDC-1308, and now consider her to be our “go to” person for toxicology...."
Endece
Dr. James Yarger, CEO
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Professional Nonclinical Services

Toxicology, Pharmacology and Pharmacokinetics

  • Project Team subject matter expertise
  • Strategic integrated nonclinical development plans
  • Comprehensive gap analysis of existing nonclinical development programs in preparation for IND submission, in-licensing and/or global registration
  • Preparation of high-quality, submission-ready eCTD nonclinical summary documents (pre-IND, IND/CTA, NDA/BLA, etc.)
  • Preparation for and subject matter expert representation during due diligence activities 
  • Scientific Advisory Board membership
  • 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 
  • Preparation for and participation in Global Health Authority (e.g., FDA) meetings 
  • Resolution of nonclinical safety-related clinical hold issues
  • Review and integration of the scientific literature 
  • Clinical starting dose selection based on nonclinical safety data