Cyton’s safety team uses its expertise in toxicology to support our clients in addressing three critical requirements for the registration of veterinary medicines:
- User Safety Risk Assessment (USRA)
- The safety of the product to users such as veterinarian, pet owners or farmers
- Environmental Risk Assessment (ERA), also known as EIA
- The safety of the product to non-target organisms such as plants, soil organisms and aquatic animals in the case of environmental exposure
- Maximum Residue Limits (MRLs) and Withdrawal Periods (WPs)
- The safety of residues from the product to consumers of the edible products derived from treated animals
The safety of the product to the animals being treated is the domain of our preclinical and clinical projects team.
Our safety team use their technical expertise to evaluate the toxicology data at the core of all safety projects, then apply 20 years of regulatory consulting experience to ensure that all data meets the requirements for the safety part of the dossier (Part 3A; USRA and EIA) and the residues part of the dossier (Part 3B; MRLs and WPs) and the requirements for the establishment of new MRLs.
For more information about Cyton’s specific services and expertise, please follow the links in the panel to the right.