Agirad

Consultancy in Human Health Toxicology & Quality (GLP) Services: 1. Study planning & monitoring support: Planning, organization, execution, as well as oversight and interpretation of regulatory relevant in vitro and in vivo toxicological studies according to GLP, OECD (chemicals),(V)ICH ((veterinary) pharmaceuticals), ISO (medical devices) and other guidelines. Regulatory & scientific issue solving-Toxicological (risk) assessment, including literature search on toxicological data, datagap analysis, hazard assessment and/or exposure assessment-Preparation of toxicology sections in regulatory documents & registration dossiers-Argumentation to Regulatory Authorities 3. Quality support -Implementation of Good Laboratory Practices (GLP)-Quality Assurance (QA): facility, process & study inspections. Training -Human Health Toxicology & GLP