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.
