Pharmacovigilance

Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Pharmacovigilance for FDA’s Center for Veterinary Medicine (CVM) is focused on the safety and efficacy of veterinary drugs in animals and people exposed to these products.

TSG has a range of experts that can comment on all aspects of veterinary pharmacovigilance, including human and animal adverse drug reactions, lack of efficacy, microbiological issues, toxicology and ecotoxicology, residues chemistry and the broader aspects of veterinary pharmacovigilance.

TSG assists with the following issues:

Development & Approval Process:
New Animal Drug Applications, Electronic Submissions, User Fees, Genetic Engineering, Minor Use/Minor Species, Aquaculture, Food Additive Petitions

Guidance, Compliance & Enforcement:
BSE, Policies & Procedures, Laws, Salmonella and Turtle Safety

Products:
Approved Animal Drug Products, Animal Food/Feed, Imports & Exports, Generally Recognized as Safe (GRAS) Notification Program

Safety & Health:
Adverse Drug Events, Product Safety, Animal Feed Safety System (AFSS), Antimicrobial Resistance, Animal Cloning, Recalls

TSG also provides the following pharmacovigilance services:

Drafting of Periodic Safety Update Reports (PSURs);

Preparing companies for internal audits and regulatory inspections;

Identifying required documents – SOPs, business procedures, manuals;

Drafting and reviewing SOPs and other related documents;

Constructing Corrective Action Preventive Action (CAPA) plans and response;

Interpreting data;

Negotiating with the FDA’s Center for Veterinary Medicine;

Expert statements and reports; and

Literature searching for adverse effects of specific products, actives, excipients and other ingredients