Regulatory Consulting Services in Europe
Dossier Development & Submission
Preparation and submission of active substance and product dossiers for EU-wide and Member State registrations.
Data Development / Study Monitoring
Identification of required studies to support registration, data gap analysis, placement and monitoring of studies at contract research organizations, review and interpretation of study results, and Good Laboratory Practice compliance consulting.
Toxicology & Chemistry Consultation
A multi-disciplinary team of CSI scientists supports registration activities by providing expert guidance on toxicology, ecotoxicology, product & residue chemistry, environmental fate, and efficacy.
Extensive experience in all aspects of human health and ecological risk assessment. Hazard identification, effects analysis, exposure assessment, and risk characterization.
Regulatory & Scientific Insights
Advice on emerging regulatory and scientific developments that may impact current and future registrations. Recommend approaches to bring client products into compliance with new legislation.
Task Force Representation / Administration
Extensive experience in co-ordination of industry task forces. Undertake both administrative and technical roles for task forces and consortia.
Regulatory Due Diligence
Comprehensive due diligence support to companies and investors prior to mergers, acquisitions, joint ventures and other activities.