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
