SERVICES PROVIDED

Premier Toxicology Consulting, LLC provides expert toxicology consultation for preclinical drug candidate registration including the following:

• Preclinical drug development program design to meet international regulatory requirements
• Design of non-GLP (investigative) and GLP preclinical toxicology protocols for acute through chronic and carcinogenicity studies
• Design of programs for small molecules as well as biologics (monoclonal antibodies)
• Evaluation of study results and preclinical report writing
• CRO study monitoring to ensure GLP compliance and scientific integrity
• Review/editing of CRO final study reports
• Evaluation of impurities/degradants in drug substances and drug products
• Due diligence review of preclinical data for in-licensing and out-licensing candidates • Literature reviews and preparation of toxicity profiles, safety evaluations, position papers, MSDS, and monographs
• Preparation of summary documents and presentations for internal and external communications
• Preparation/review of preclinical sections of regulatory submissions including IND/NDA, CTD, expert reports, and Investigator Brochures
• Interaction with FDA and international regulatory agencies; responses to regulatory agency questions on submissions