Animal FDAs CVM

The FDA’s Center for Veterinary Medicine regulates products like endectocides, growth-promoting agents, anabolic steroids, antibiotics, anesthetics, anthelmintics, fungicides, bactericides and virucides. TSG assists clients with new and supplemental animal drug applications, marketing through regulatory discretion, compliance issues and general regulatory support.

Services include:

New Animal Drug Application (NADA)
Defining and describing manufacturing process
    – Product characterization
    – Analysis of typical production
    – Development/validation of monitoring and
       evaluation methods
    –
Compliance with Good Manufacturing Practice (GMP) guidelines
    – Product storage and distribution
Animal safety & tolerance
Product efficacy
Study Design and Monitoring
    – Toxicology studies
    – Metabolism of active ingredient in target and non-target species
    –
Environmental fate
Environmental assessment
    – Assessment studies
    – During administration
    – Post administration
Residues in target animals
    – Assessment studies
    – Toxicological evaluation of residues
Prepare and interpret technical information for FDA
Interface with FDA
    – Act as client representative
    – Present data to FDA at all phases