Make better decisions for health and safety.
Our Expertise
Regulatory Strategy and Submission
Leverage our expertise to develop and execute comprehensive plans aimed at navigating regulatory requirements and submitting necessary documentation for product authorization.
Chemical Characterization
Characterize the chemical profiles of tobacco and cannabis products in terms of ingredients, materials/leachables, chemical and physical properties of liquid formulation and aerosol.
Stability Study Design and Testing
Assess product performance under various usage conditions over time, and evaluate long-term chemical and microbial stability throughout the expected shelf life.
Toxicology Study Design and Testing
Design and oversee in vitro toxicity assays to assess the mutagenic, cytogenic, and genotoxic potentials of the candidate products relative to combustible cigarettes.
Product Specification and Manufacturing
Collect materials and draft documentation to define detailed requirements and processes aimed at ensuring consistent quality and performance during the manufacturing of tobacco products.
Risk Assessment
Use a systematic approach to evaluate potential excess lifetime cancer risk (ELCR) and noncancer health risks for consumers associated with chemical exposures to ingredients, leachables, and aerosol emissions of the new product relative to combustible cigarettes and market products.
Extractables and Leachables
Design extractable and leachable studies of electronic cigarettes and medical devices to assess worst-case extraction under exaggerated conditions (extractables) or migration under more typical use conditions (leachables or simulated-use extractables). Testing can be conducted on individual components or the final finished product. These data are then evaluated in the toxicological risk assessment (TRA) to determine potential risk to the end user.
Product Development
Help companies develop responsible products by toxicologically screening ingredients and materials to minimize potential health risks to consumers, meet regulatory requirements and expectations, and bring the products to market.
Medical Devices Toxicological Risk Assessment
Conduct toxicological risk assessments of extractables (e.g., exaggerated, exhaustive, or simulated-use) or leachables data in accordance with the latest standard (ISO 10993-17:2023) to characterize potential risks and refine the biological testing plan. The TRA can evaluate patient exposures via the oral, dermal, inhalation, and parenteral routes of exposure, depending on the intended use of the device. The TRA is a critical first step for evaluation of several biological endpoints, including: systemic toxicity (acute, subacute, subchronic, chronic), genotoxicity, carcinogenicity, and developmental and reproductive toxicity.