Our team of experts design and execute product assessment and testing programs to help you access markets and get your product into the hands of consumers.
We work smart by leveraging our advisors’ knowledge and experience in the industry, and by getting to know your product and your business goals we can quickly help you to access markets.
Our SME’s will design and implement scientific assessments of your product, including any nonclinical, clinical or behavioral studies necessary for a successful market launch.
While generating data is a necessary component on the route to market, successful launches clearly lay out study insights which tell regulators, consumers and other stakeholders about your product.
SOUND REGULATORY STRATEGY ≠ MOST EXPENSIVE STRATEGY
A sound regulatory strategy is about the team in play.
Founded by Dr. Willie McKinney, a veteran tobacco and nicotine industry executive who served as an industry representative on the FDA Tobacco Products Scientific Advisory Committee, the consultancy relies on a collaborative group of experts boasting a combined experience of over 200 years.
We rely on established relationships to help manufacturers navigate complex, changing regulatory environments.
Product Design and Controls
- Ensure product materials and ingredients meet appropriate standards
- Verify manufacturing standards and quality controls are fit-for-purpose
- Demonstrate products are stable over time
- Ascertain materials and ingredients are appropriate for their intended use
- Determine if product constituents are toxicologically acceptable
- Assess use patterns to inform risk assessments
Chemical and Physical Characterization
- Assess levels of harmful and potentially harmful chemicals in your product
- Determine levels of impurities
- Conduct non-targeted analyses to understand other chemicals present in your product
- Analyzing inhalability by assessing particle size
- Measuring mastication and dissolution to understand chemical and ingredient release
- Assess a product’s mutagenicity, cytotoxicity and carcinogenicity
- Understand a product’s in vivo effects in complex, biological systems
- Assess product use and exposure to active ingredients in your product
- Assess biomarkers to understand efficacy and other clinical effects
- Assess real-world patterns of use
- Understand user behaviour, including what led users to start using your product
- Evaluate labels and use instructions to ensure they are clear and easy to understand
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