Sector
Animal Health & Feed
CSI supports animal feed registrations in the United States, facilitating feed product registrations, annual renewals, tonnage reporting, and label review. We focus on accurate, efficient submissions for companies managing multi-state portfolios.
We also 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) and EU User Risk Assessments (URA).
Experienced Support For:
- Label Development and Compliance
- Regulatory Strategy
- Dossier Preparation & Submission
- Regulatory Agency Liaison
- Human Health & Environmental Risk Assessment
- Task Force Representation & Administration
- Applied Economic Support
Animal Feed Registration Support in the United States
Livestock feeds, pet food, pet treats, and functional feed additives must be registered in every U.S. state in which they are produced, sold and/or distributed, including each brand and separately packaged quantity. Registration requirements are further defined according to product classifications and labeled claims. Once products are registered, efficient registration management is critical to ensuring products stay in compliance so that customers do not experience a gap in availability of their favorite products.
Our staff can provide efficient and cost-advantaged support to address regulatory requirements in this unique industry via the following:
- Product classification
- Label development
- Ingredient and label compliance review
- Regulator liaison
- Multi-state and multi-product submission management
- Registration maintenance (renewals, tonnage, label amendments)
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.
