We provide data evaluation, exposure modeling, and regulatory support to meet the requirements of animal health product legislation. Our regulatory consultants specialize in the preparation of EU Environmental Risk Assessments (ERA), US Environmental Assessments (EA), and EU User Risk Assessments (URA).
We also provide commercial and pet food manufacturing facility and product registration, renewal, and tonnage reporting services across the US.
Experienced Support For:
- Global Regulatory Strategy
- Dossier Preparation & Submission
- Regulatory Agency Liaison
- Human Health & Environmental Risk Assessment
- Task Force Representation & Administration
- Applied Economic Support
Animal Health Support in North America
Animal health products used in the US are potentially subject to Food and Drug Administration (FDA) environmental assessment (FDA-EA) requirements. The FDA’s Center for Veterinary Medicine (CVM) is responsible for environmental evaluations. Registrants are required to prepare an EA or, if applicable, submit a categorical exclusion for their product.
If required, the FDA-EA includes tests for physical/chemical characterization, biodegradation properties, microbial inhibition, environmental fate, and environmental effects. We can coordinate study placement and monitoring for these tests to aid in meeting these requirements.
We also offer support for animal health products where the US Environmental Protection Agency (EPA) or US Department of Agriculture (USDA) have jurisdiction over product registration.
Animal Health Support in Europe
Environmental safety of veterinary medicinal products and animal feed additives in the EU is regulated under Directive 2001/82/EC, to be replaced by 2019/6 in January 2022.
Our staff 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).
- 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 product lines.