Regulatory Consulting Support for Animal Health Products
Animal health products used in the U.S. are potentially subject to Food and Drug Administration (FDA) environmental assessment requirements. The FDA’s Center for Veterinary Medicine (CVM) is the entity responsible for such evaluations. Registrants must prepare an Environmental Assessment (EA) or, if applicable, submit a categorical exclusion for their product. If required, the FDA-EA would include tests for physical/chemical characterization, biodegradation properties, microbial inhibition, environmental fate, and environmental effects. CSI can coordinate study placement and monitoring for these tests. For certain product applications, the U.S. Environmental Protection Agency (EPA) or U.S. Department of Agriculture (USDA) may have jurisdiction – CSI can also support these needs.
Environmental safety of veterinary medicinal products and animal feed additives in the European Union is regulated under Directive 2001/82/EC. Staff at our European Headquarters can provide data evaluation and regulatory support to meet these requirements including: risk evaluation for aquatic and terrestrial systems, exposure modeling, calculation of predicted environmental concentrations (PECs), and coordination of necessary higher-tier aquatic and terrestrial field studies. Phase I and Phase II environmental risk assessments are prepared in compliance with EU guidance. We can also provide advice on the impact that legislative amendments may have on the continued authorization of your product line.
The regulatory arenas and the regulated industries we serve continue to change. As a company, CSI’s strength has come not only from being able to adapt to industry trends, but by anticipating and applying new regulatory and scientific strategies to add value to client product development and registration pathways. Keeping pace in our consultancy has required us to stay current on regulatory drivers and scientific approaches to deliver our best for each individual client and project. We extend this dedication to you.
If you would like further information about CSI’s services in the Animal Health sector, please Contact Us.