Building Trust to Minimize Harm
Your regulatory partners in bringing better nicotine and cannabis products to market.
Nicotine
In an evolving regulatory environment, where the laws can be unclear, you need an agile partner to stay abreast of changing policy and tell you what you need to hear in order to remain compliant.
Cannabis
Are you ready for the regulatory wave? Self regulation, by understanding the science behind your product and the impact of your marketing, is the best offense and critical in helping to shape this emerging industry.
Navigating rapid industry shifts requires trustworthy advisors
who have YOUR best interests in mind.
Our Process
Regulatory compliance is a marathon. We arm businesses with the tools to stay in the race.
Assess
We’ll look at your design, manufacturing and marketing approach with a regulatory lens to identify strengths and opportunities.
Strategize
Compliance doesn’t always mean starting from scratch. Leverage our team’s industry knowledge to build a regulatory roadmap.
Test
Understanding your product on a cellular level is the key to harm reduction. Our team goes beyond the data, helping you make sense of those insights.
Submit
Successful PMTA submissions don’t just spout facts. The FDA needs a compelling narrative that demonstrates your product is suitable for safeguarding public health. We help you tell your story and champion your product to market.
Improve
Whether its post-submission or post-authorization, we’ll help you maintain compliance through the life of your product.
Our Insights
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4 min. read
Summary of the Judgement, Wages and White Lion Invest v. FDA, No. 21-60766 (5th Cir. 20244)
By majority (10-6) opinion the United States Court of Appeal for the Fifth Circuit has determined that the Premarket Tobacco […] Read More
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8 min. read
Tobacco harm reduction for people with mental health needs
Enhancing Tobacco Harm Reduction through Holistic Approaches By Cheryl K. Olson “I firmly believe a lot of us, people like […] Read More
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1 min. read
Global Regulatory Requirements and Developments Implications for Tobacco Products
Understanding the Transformation: Unpacking International Tobacco Legislation, Upcoming TPD Changes, FDA CTP’s Role, and the Evolving Global Regulatory Scenario Read More