Veterinary Safety

PharSafer® are also involved in ensuring safety for medicines used in the veterinary field. Veterinary medicines have their own set of stringent regulations which must be followed to ensure animals are provided with the best medicines that provide maximum benefit and 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 and even within 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.

Clinical Trials

The approval of Veterinary medicines for sale also means that the products have to be rigorously tested prior to licence submission and approval through clinical trials and PharSafer® can help in assessing the safety aspects from such clinical studies and reporting as well as the information needed for licence approval and any post-marketing safety commitments/studies that have to be performed as part of the licence approval.

Licence agreements & Regulatory Inspections

In addition, the setting up of any licence agreements for marketing partners to ensure the transfer of both medical enquiries and pharmacovigilance activities together with any due diligence activities in the acquisition of products or Companies involved with animal medicines can also be performed by PharSafer® personnel to ensure a smooth transition to your own Company.

So, whether for specific Projects or the handling of all of the pharmacovigilance activities and medical services, we are here to help. Please enquire as to how we can help you with your Veterinary safety and medical service requirements.