Call: +44(0)1954 268200

Full dossier support

  • Strategy, data gap analysis and preliminary risk assessment
  • Overview of regulatory requirements and processes
  • Review of existing data and identifying data gaps
  • Preliminary risk assessments for human health and the environment for each relevant substance, data sharing and data generation
  • Literature search and review
  • Letters of access and data sharing negotiation
  • Study placement, design and monitoring
  • Data review and evaluation
  • Dossier preparation (IUCLID 6, SPC Editor)
  • Human health and environmental risk assessments
  • Representation at meetings with regulators
  • Robust study summaries
  • Summary of the product characteristics (SPC)
  • Dossier submission (R4BP 3) and follow-up.

Contact

Meet the team

Adrian Terry

Head of CEA