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.