menu
Professional Toxicology Services
"In 2007, Kalypsys took a chance by signing on as Grace’s first client as an independent consultant. Her work on that project immediately justified the risk taken..."
Kalypsys, Inc.
John Fikes, PhD, VP
view all testimonials

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