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Vaping Supplies

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. 

Want to participate in our cost sharing programs?

Sanova offers cost sharing programs for literature reviews, survey analytics and ingredient assessments that are customized to support harm reduced tobacco products.

CONTACT US

Want to discuss our services or interested in joining our team?  Let us know.  

Want to talk to someone?  Call us at (888) 415-9926.

Sanova.co

1806 Summit Avenue

Suite 300 #228

Richmond, Virginia 23230

(888) 415-9926

www.sanova.co

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