PharSafer® is also involved in ensuring safety for medicines used in the veterinary field. Veterinary medicines have their own set of stringent regulations similar to pharmacovigilance in humans. These regulations must be followed to ensure animals are provided with the best medicines, providing maximum benefit and minimum risk. The complex nature of the Veterinary medicines arena is compounded by the fact that the wide variety of different species may react very differently to the same medicine. Even within a species, the complex nature of understanding different dosages and different weights for animals, together with changing pharmacokinetics due to age and gender differences, produces its own unique set of challenges apart from human Pharmacovigilance.
Veterinary Qualified Person
PharSafer® has the expertise to help in this area. From adverse reaction case processing, answering veterinary enquiries into the product usage (veterinary information), understanding the varied legislation, providing aggregate data assessments (safety reviews), Periodic Safety Update Report (PSUR) writing, provision of a Veterinary Qualified Person for Pharmacovigilance, helping to keep labelling up to date, literature searching for possible adverse reactions and attendance for possible Regulatory Inspections.
For Veterinary medicines to get approval for sale means that the products have to be rigorously tested prior to license submission and approval through clinical trials. PharSafer® can help in assessing the safety aspects from such clinical studies and reporting. We can also guide companies through the requirements for license approval and any post-marketing safety commitments/studies needing to be performed as part of the license approval.
Licence agreements & Regulatory Inspections
In addition, we can assist in the setting up of any license agreements for marketing partners to ensure the transfer of both Medical Enquiries and Pharmacovigilance reports. PharSafer® can also carry out any due diligence activities in the acquisition of products or companies involved with animal medicines to ensure a smooth transition to your own company.
Whether it is for specific projects or the handling of all of the Pharmacovigilance activities and medical services, we can help. Please contact us for more information.