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Harm Reduction
End-to-end regulatory and scientific support to navigate a complex and evolving regulatory environment.
Making a Public Health Impact
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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.
Gap Assessments, Deficiency Letters and Amendments
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.
Agency Presentations & Meetings
Our team has extensive experience with pre-submission meetings and advisory committee meeting preparations for tobacco products (TPSAC). We provide broad support including preparation of request letters, briefing materials, presentations, and Q&A materials. We can also identify scientific experts to participate in the meeting to supplement your response team.
Quality Management Systems
While the FDA draft regulations on Tobacco Product Manufacturing Practices (TPMPs) have not been finalized, many manufacturers are seeking assistance with setting up compliant QMS systems or reviewing existing systems for compliance. Sanova has experts who can assist with establishing a new QMS from the ground up, auditing an existing system, making sure you are ready for inspection or just helping fill in gaps.
