Superior Environmental Consultancy, Llc

Superior Environmental Consultancy is committed to supporting companies achieve their compliance goals and move beyond environmental compliance. Our primary service is support with U.S. Food and Drug Administration (FDA) regulations as it relates to National Environmental Policy Act (NEPA) Environmental Assessments (EAs) for tobacco products. Our team has developed environmental assessments for thousands of tobacco products, supporting our clients since the beginning of these NEPA requirements on the tobacco business sector. This experience includes all types of products (e-cigarettes, e-liquids, smokeless/pouches/snus, gums, cigarettes, etc.) for all types of applications and submittals to the FDA. Overall, our extensive experience enables us to execute and deliver superior deliverables in a cost-effective manner. We are committed in supporting the tobacco sector’s move to healthier or reduced-risk products- Development of Environmental Impact Assessments or Environmental Assessments for tobacco products that are submitting applications (or similar) to the FDA. Environmental Assessments are required for- Premarket Tobacco Product Application (PMTA)- Modified Risk Tobacco Product Application (MRTPA)- Substantial Equivalence (SE) Application - Request Exemption from Demonstrating Substantial Equivalence (EX REQ)- Responding to official questions from the FDA on Environmental Assessments which typically are issued during the Substantive Review. Other Environmental Services include- Environmental Compliance and Management - Air Quality compliance and permitting - Environmental policy and strategy – Strategic planning, Environmental applicability analysis, and Environmental technical and regulatory management - Implementation of existing, modified, and new environmental regulations - Environmental compliance auditing - Negotiating environmental enforcement and/or violations (non-compliance)- Environmental Information Management Systems (EMIS)