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A Premarket Tobacco Application (PMTA) is required by the U.S. FDA for any new tobacco product seeking authorization to be legally marketed in the United States. The application must demonstrate that the product is “appropriate for the protection of public health (APPH)”, supported by robust scientific evidence.
Navigating the FDA Premarket Tobacco Application (PMTA) process is complex, data-intensive, and highly regulated. At RIAR Consulting, we provide end-to-end PMTA consulting services to help tobacco, nicotine, and ENDS (e-cigarette/vape) manufacturers achieve FDA authorization with confidence.
Our regulatory experts combine scientific, regulatory, and strategic expertise to ensure your PMTA submission meets all FDA Center for Tobacco Products (CTP) requirements.
We don’t just prepare submissions — we build defensible regulatory strategies aligned with FDA expectations.
Compile, review, and submit a complete, high-quality PMTA dossier, ensuring scientific rigor and regulatory compliance.
Provide post-market complian & lifecycle management support to maintain authorization and long-term market success.
We help you maintain authorization, reduce regulatory risk, and stay inspection-ready throughout the product lifecycle.
Whether you are preparing a new PMTA, responding to FDA deficiencies, or planning future product authorizations, RIAR Consulting is your trusted regulatory partner.
Stay informed with RIAR Consulting as we share key regulatory updates, compliance insights, and global market access guidance.Your trusted partner for efficient approvals across SFDA, US FDA, EU, UK, and India.
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