Services
We are committed in supporting the tobacco sector’s move to harm-reduction 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)
Project Experience
- Development and implementation of comprehensive FDA Environmental Assessment programs
- Development of environmental assessment methodologies which have included various types of quantitative (exposure modeling or analysis) and qualitative evaluations
- Development of environmental assessment strategies for various categories of tobacco products
- Completion of hundreds of FDA Environmental Assessment projects for well over a thousand products involved in substantial equivalence determinations and substantial equivalence exemptions
- Completion of FDA Environmental Assessments for hundreds of products in the various product categories (e-cigarettes, ENDS, etc.) in premarket tobacco applications (PMTAs) or modified risk tobacco product applications (MRTPAs)
SERVICES
With decades of top experience, our team can advise businesses of any scale! Our company’s history starts 20 years ago when we’ve decided to make the world a better place for those, who are the owners or smaller business! By now we’ve helped hundreds of top-flight companies and thousands of SMBs to call the right decisions on internal management, M&As, etc.