Who We Serve

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. 

Markets Served

  • Reduced Harm Nicotine Products
    • E-Cigarettes and Electronic Nicotine Delivery Systems
    • Modern Oral Nicotine Products
    • Smokeless Tobacco
  • Nicotine Replacement Therapy (NRT)
  • Cannabis/CBD
  • Regulated and currently non-regulated consumer products
  • Nutraceuticals/dietary supplements

Functional Areas Served

  • Regulatory Affairs
  • Scientific Affairs
  • Marketing
  • Legal
  • Quality Assurance
  • Product Management


Typically, our clients approach us for help in the following areas:
Scientific and regulatory support for filing a PMTA for their product(s)

Development of a new product that complies with FDA requirements 

Product formulation evaluations including conducting quantitative risk assessments (QRA)

Study design and interpretation of analytical chemistry and toxicology test results
Design and completion of consumer-research studies 

Improvement of their quality-management systems

Targeted or systematic literature search and review
Completion of a population-modeling assessment 

Examination of national survey data related to specific subpopulations and user behaviors (e.g., PATH, NYTS)

Scientific litigation support in areas such as intellectual property, product liability and mass tort litigation


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.

Learn More & Get 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.