Environmental Risk Assessment (ERA) services

The requirements for evaluation of a veterinary medicine’s potential environmental impact have increased dramatically over the past 10 years; both industry and the regulators have struggled to keep up with the regulatory aspects and the science behind Phase II ERAs. Cyton has been working on ERAs throughout this transition period and is, therefore, always aware of the latest developments in the assessment of environmental impact.

As a member of the knoell group, Cyton has access to unparalleled environmental experience in the agrochemicals sector where the state of the art is many years further advanced compared to the veterinary medicines sector. The knoell group’s experts complement Cyton’s safety team to give confidence in the addressing even the most complex ERA, where established guidelines for the veterinary sector may not yet be in place.

Our specialist services and expertise for ERAs

  • Preparation of ERAs in accordance with CVMP/VICH guidance
    • Phase I and Phase II Tier A assessments
    • Phase II Tier B assessments with advanced expertise in e-fate
  • Computer simulation of e-fate using established modelling scenarios (FOCUS)  
  • Consortia management – independent third party support for companies seeking to work together and share the costs of generating a complete ecotox data package
  • Data audits, gap analysis and literature reviews (find out more here)
  • CRO selection; study design and reporting (find out more here)
  • Dossier writing, DACS (Expert Reports) and responses to questions (find out more here)

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