Antimicrobial Registration Services in the USA
EPA Regulatory Affairs
Regulatory strategies for EPA and FDA regulated antimicrobial products. Agency liaison, registration package preparation and submission.
State Registration Management
First-time registration approvals in all 50 states, District of Columbia, and US territories. Annual renewal of product licenses according to individual State schedules and fees. State submission packages (applications, labels, MSDSs, technical data, reports, authorization letters, product summaries).
Efficacy Data Development / Study Monitoring
Identification of required studies to support product efficacy. Placement and monitoring of tests at contract research organizations, review and interpretation of study results.
Toxicology & Product Chemistry
CSI scientists support registration activities by providing expert guidance on toxicology, ecotoxicology, and product chemistry. Study placement and monitoring for required GLP data.
Extensive experience in all aspects of human health and ecological risk assessment. Hazard identification, effects analysis, exposure assessment, risk characterization.
Regulatory & Scientific Insights
Advice on emerging regulatory and scientific developments that may impact current and future registrations. Recommend approaches to bring client products into compliance with new regulations.
Task Force Representation / Administration
Client representation on industry trade association consortia. Senior CSI staff serve in administrative and lead technical roles on chemical task forces.
Data compensation evaluations; intellectual property assessment; scientific case preparation; expert witness testimony.