Registrations & Approvals:
Animal Health Products - FDA's CVM
(FDA's
Center for Veterinary Medicine)
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
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