Product Testing
Our Approach
Our team of experts design and execute product assessment and testing programs to streamline approval and help you gain market access advantage.
We work smart by leveraging our advisors’ industry knowledge and experience, utilizing existing product data, where available, to demonstrate that your product meets all regulatory standards.
If the existing scientific data doesn’t warrant a bridging strategy, our SME’s will design any nonclinical, clinical and/or human behavioral studies necessary for a successful regulatory submission.
While data are a necessary piece of the submissions process, successful applications clearly lay out study insights. We also maintain relationships with regulatory and public health stakeholders to ensure no stone goes unturned.
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 the 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.
Scientific Capabilities
Product Design and Controls
- Ensuring that product materials and ingredients meet product design standards
- Ensuring compliance with manufacturing standards and quality controls
- Measuring product stability over time
- Ensuring battery and circuit safety standards
Risk Assessment
- Constituents – assessing if constituents are toxicologically acceptable
- Ingredients – making sure ingredients are appropriate for their intended use
- Constituents – determines if constituents are toxicologically acceptable
Chemical and Physical Characterization
- Determining levels of Harmful and Potentially Harmful Constituents (HPHC)
- Evaluating the levels of impurities (such as metals)
- Performing non-targeted analysis to understand chemicals present
- Analyzing inhalability by assessing particle size
- Measuring mastication and dissolution to understand chemical and ingredient release
Nonclinical Studies
- Assessing a product’s mutagenicity or potential to change DNA
- Measuring a product’s cytotoxicity or potential to kill cells
- Understanding a product’s in vivo effects in complex, biological systems
Clinical Studies
- Pharmacokinetics/abuse liability/puff topography – measuring chemical uptake and abuse potential of new products
- Biomarkers – understanding changes in relevant human biomarkers after use of the new product
Behavioral Studies
- Looking at the perceived risk and likelihood to try new products
- Understanding product actual use patterns and measure user behavior in-market
- Evaluate labels and use instructions to ensure they are clear and easily understood
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