Edge Toxicology Consulting Limited

independent consultant with 15+ years of nonclinical and toxicology experience within various medical/pharmaceutical settings. non-clinical development capabilities: proficient in the design, preparation and implementation of in vivo and in vitro studies related to all non-clinical development activities; expertise across various therapeutic areas, including numerous modes of administration and various animal species; can act as single point of contact in monitoring and coordinating outsourced studies; author non-clinical safety sections of briefing documents, investigator brochures (ib), investigational new drug (ind) and clinical trial (cta) applications; regulatory non-clinical queries. biocompatibility and toxicology risk assessment capabilities: biological risk assessments, evaluation plans, gap analyses and reports, in compliance with iso 10993-1, iso 10993-17 and iso 14971; design and preparation of in vivo and in vitro studies related to all biocompatibility development act