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Building Trust to Minimize Harm

Your regulatory partners in bringing better nicotine and cannabis products to market.

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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.

Learn How

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.

Learn How
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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.

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Our Insights

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