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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3 min. read
Dr. Willie McKinney Speaking at FDA CTP Listening Session: Aug. 8, 2023
On August 22, 2023 our very own Dr Willie McKinney, CEO, had the opportunity to express his views and opinions […] Read More
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Hey Doc: Do You Really Want to Stop Your Patients From Smoking?
For patients who can’t quit smoking there are several reduced-harm alternatives. None of these alternative nicotine products are safe. They […] Read More
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4 min. read
Unlock the Benefits of ITP: A Comprehensive Guide to Investigational Tobacco Product Applications
It’s no secret that the FDA’s requirements for investigational tobacco product (ITP) applications can be confusing. But what if you […] Read More