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)

PMTA EXPERTISE

E-Liquid Products

ENDS Products

Oral Nicotine Products

Grouped PMTAs

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.