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
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
Eicarte LLC Services
Committed to achieving company drug development goals as an integral team member.