Cambridge Environmental Assessments (CEA) provides specialist regulatory support and consultancy to pharmaceutical industry clients seeking to (re-)register their veterinary medicine products covering both terrestrial and aquaculture products. Specialising in the Environmental Safety section of the dossier, our veterinary medicine specialists can provide non-clinical regulatory support for your active/product through the entire regulatory process, including:

• Product development and defence strategies
• Product advocacy meetings with Member State regulators
• Data gap analysis
• Literature reviews
• Placement and monitoring of studies
• Environmental risk assessment, in particular Phase II, higher tier risk refinement and mitigation
• Dossier section preparation
• Responding to questions from Member State regulators
• Preparation and presentation of position papers
• Training of clients and regulators
• Software development

Please contact us to discuss your veterinary medicine needs.