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Harm Reduction
End-to-end regulatory and scientific support to navigate a complex and evolving regulatory environment.
PMTAs and Other Regulatory Submissions
We have a proven track record of success with PMTA submissions, from pre-submission activities to postmarket surveillance. We can plan and execute your PMTA strategy, oversee study design and conduct, and prepare all dossiers for submission. We also have significant experience with other submission types including SEs, MRTPAs, ITPs, and TPMFs.
Literature Cost Sharing
We conduct annual literature reviews for the major tobacco product categories, which we offer to clients at a fraction of the cost through cost-sharing arrangements. Our approach to literature reviews lowers the costs to industry and reduces the burden on regulators who review this expansive information. Our reviews are suitable for PMTAs, MRTPs, ITPs, product development, market assessment, and more.
PMTA Rescue
We can conduct gap assessments of your pending PMTA and propose next steps that will extend your time on market and improve the likelihood of market authorization. We also provide support for deficiency letter responses, resubmissions, and amendments.
Data Analytics
Our team carefully monitors nationally representative surveys, like NYTS and PATH, and provides additional analytics beyond those provided in the top line survey results. We have unique insights regarding the data's utility in supporting regulatory submissions and informing strategic decision-making.
Product Design
Our specialists -- from chemists and toxicologists to regulatory specialists and data scientists -- can help you thread the needle between projected revenue and costs, desirability, capability and viability. We specialize in recommending product design alterations that can increase your likelihood of regulatory success.
TPSAC Support
Our team has extensive experience with advisory committee meeting preparations for tobacco products. We provide broad support including preparation of briefing materials, presentations, and Q&A materials. We can also identify scientific experts to participate in the meeting to supplement your response team.