Diverse clients. Unique NEeds.
Our clients develop and distribute products in a variety of markets including vaping and e-liquids, tobacco, nicotine replacement therapy, cannabis/CBD, nutraceuticals/dietary supplements, and other consumer products.
Development of a new product that complies with FDA standards
Product formulation evaluations including conducting quantitative risk assessments (QRA)
Improvement of their quality-management systems
Examination of national survey data related to specific subpopulations and user behaviors (e.g., PATH, NYTS)
Our clients typically contact us as they begin to prepare for a Premarket Tobacco Product Application (PMTA) submittal. Oftentimes, they have not previously designed regulatory-facing studies or submitted regulatory applications. We create a PMTA roadmap, guiding our clients through every step of the complex process.
We present goals, explain requirements, embark on study design, conduct research, develop strategy, and prepare a complete submission. We can also support our clients beyond submission with follow-up correspondence, responses to deficiency letters, post-market surveillance, and design and execution of annual reporting requirements. Click below to see a simplified version of our PMTA roadmap.
Consilium’s mission is to be the leading provider of regulatory solutions for materials science, vaping, tobacco and cannabis products. This includes preparation of PMTAs, SEs, MRTPAs and TPMFs as well as other regulatory documents for the FDA, EMA and Health Canada. Our emphasis is on harm-reduction products.