Veterinary medicines

Veterinary medicines

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.

 

Environmental fate and exposure

Data gap analysis


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Risk Assessment

Risk assessment


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Software

Software


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Training

Training


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