Scientific and regulatory solutions for materials science, vaping, tobacco and cannabis organizations with a focus
potentially harm-reduced products.

A diversity of clients. An abundance of solutions.

Consilium’s clients range from multi-billion-dollar corporations to smaller, privately held companies. Our recent focus has been supporting clients in preparing numerous Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) applications, as well as rapid turnaround scientific litigation support. 

At Consilium we take pride in developing strong relationships with clients and understanding their unique needs so that we can build the right team of scientific experts to develop and implement quality solutions. Our global network of mostly doctoral-level scientists and clinicians includes expertise in nanotechnology, materials characterization, toxicology, pharmacology, epidemiology, chemistry, GMP, consumer research, regulatory engagement, post-market surveillance, literature reviews, statistics and more.

What We Do

We develop and provide scientific and regulatory solutions and regularly engage with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada.

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Who We Serve

Consilium’s clients include tobacco, vaping and cannabis organizations ranging from multi-billion-dollar global corporations to smaller,
privately held companies.

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eLiquid Products
Device Products
Applications Submitted
PMTA Clients

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.

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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 potentially harm-reduced products.