User Safety Risk Assessment (USRA) services

The User Safety Risk Assessment (USRA) takes into consideration any possible human exposure to the product under commercial conditions, including exposure to veterinary professionals, farmers and pet owners, including children. User safety must therefore be factored in from the start of the product development process, particularly when planning product packaging and labelling, to avoid unnecessary and costly restrictions on the terms for marketing your products. With 20 years of consultancy experience and a dedication to regulatory intelligence, Cyton is intimately aware of both the formal guidelines for USRAs and also the specific requirements of individual national competent authorities. By working together with our CMC experts, our safety team can advise you on how to develop a product which is safe to the user, without compromising the commercial success of your product.

Our specialist services and expertise for USRAs

  • Qualified toxicologists with expertise in all core toxicological endpoints
  • Identification of the need for specific ‘user safety studies’, with subsequent CRO selection, study design and reporting:
    • Dermal irritation
    • Dermal sensitisation
    • Eye irritation
    • Inhalation irritation
    •  ‘Specialist’ studies, such as a dislodgeability studies
  • Preparation of qualitative and quantitative USRA in accordance with EMEA/CVMP/543/2003 Rev. 1 for all species and all product types
  • Preparation of USRA for topical products based on most current guidelines (find out more here)
  • 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)