What We Do

Scientific Solutions to Complex Problems.

We offer a wide range of consulting services to our clients from materials characterization through research and development strategy and regulatory submissions. Our team routinely engages with clients for defined, narrow-scope projects, as well as long-term strategic support. We pride ourselves on being a transparent, highly experienced partner, sensitive to our clients’ needs. 

Regulatory Services:

  • PMTA, SE, MRTPA and TPMF preparation and submission
  • Regulatory strategy development
  • FDA briefing documents/briefing books 
  • FDA Advisory Committee Meetings (Ad Coms)
  • Risk assessments
  • Material and ingredient analyses
  • Study design and identification of Harmful and Potentially Harmful Constituents (HPHC)
  • Understanding Appropriate for Protection of Public Health (APPH) determinations
  • Guiding responses to deficiency letters and other communications with FDA and other global regulatory authorities.

Scientific Services:

  • Scientific writing
  • Product evaluation, design and testing
  • Institutional Review Board (IRB) submissions
  • Development and review of Quality Management Systems (QMS)
  • Good Manufacturing Practices (GMP)
  • Consumer research and population modeling
  • Systematic and/or comprehensive literature reviews
  • Toxicological analyses
  • Clinical study design
  • Chemistry, Manufacturing, Controls (CMC) guidance – review, audit, repair, report
  • Scientific litigation support
  • Publishing management including the eTTD (Electronic Tobacco Document)


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

The Network

Consilium employs a core group of full-time, senior-level Principal Scientists, combined with the broader Consilium Scientific Network of more than 300 consultants from across the globe.  This unique distributed-consulting approach allows us to build cost-efficient, project-specific teams that solve our clients’ needs quickly and effectively.  Our Network includes more than 300 mostly PhD, MD, PharmD and JD-level experts.  Typically, a Consilium project team will have one or more of our full-time consultants leading the project. Our teams are custom-built and project-specific, ranging in size from one individual up to a 40-person team.