Consilium supports numerous clients as they prepare for Premarket Tobacco Product Application (PMTA), Substantial Equivalence (SE), and Tobacco Product Masterfile (TPMF) submittals. Consilium offers scientific and strategic regulatory support by guiding clients through every step of the complex tobacco regulatory process including designing regulatory-facing studies or submitting regulatory applications. We are well versed in all areas of tobacco regulatory including administrative, integrated summary, chemistry, manufacturing, and control (CMC), nonclinical studies, clinical individual studies, clinical population studies, and enviornmental assessments, as well as compiling all information and studies of a PMTA into the seven modules of the electronic tobacco technical document (eTTD) format.
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. 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. At Consilium, we present goals, explain requirements, embark on study design, conduct research, develop strategy, and prepare complete regulatory submissions. Consilium also supports clients beyond submission with follow-up correspondence, responses to deficiency letters, post-market surveillance, and design and execution of annual reporting requirements.
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