Full PMTA Development
& Submission

Our team has been working with clients on their PMTA submissions since 2016, submitting applications for over 800 tobacco-based nicotine and synthetic nicotine products to date (all of which are currently still in the Substantive Scientific Review phase of the PMTA process). Through this experience, our team has developed a tried-and-true process for developing and submitting your PMTA, start to finish. Whether you are submitting an application for one product or one thousand products, our team is ready with full-service regulatory solutions for all your PMTA needs, big and small.

New Product Development
Regulatory Strategy

If you are currently developing, or plan to develop, a new tobacco product to bring to the US market, consulting with a regulatory specialist prior to full-scale production could be critical to your product’s success. When regulatory compliance is not built into the product development pipeline, companies risk losing time and money on fully developed product lines that may not meet US regulatory standards, making them ineligible for market authorization. Speaking with a regulatory consultant early in the product development process allows you to optimize your product designs to meet US design and material compliance standards prior to manufacturing, avoiding costly mistakes

At Accorto, we’ll will work with you to build regulatory compliance into every stage of your product development pipeline, ensuring your product is ready for the US market from the start.

Application Amendment Services

Are you confident in the quality of your PMTA submission? Does the data included in your application appropriately address the Agency’s current thinking on the APPH argument? Your PMTA doesn’t have to end at initial submission. The Agency allows amendments to be made to your application throughout the review stage to give applicants the opportunity to provide additional data as it becomes available. If you aren’t fully confident in the quality of your current submission, partnering with a trusted regulatory specialist to develop a strategy to review and amend your application could save your PMTA from Market Denial

Through our PMTA amendment program, our team of regulatory specialists will conduct an in-depth gap analysis of your application, providing a comprehensive strategy to address deficiencies and supplement areas of study now required to meet the FDA’s new standard for Appropriate Protection for Public Health (APPH) argument. Once areas of deficiency are identified, our team will work collaboratively with you to address these topics by designing bespoke studies to meet your specific needs and budget.

Common Areas of Deficiency:

• Clinical Studies
• HPHC Testing
• Toxicology and Stability Testing
• Marketing Plans
• Absent or Incomplete Switching Effectiveness Studies
• Lack of Randomized Control Trials or Longitudinal Data
• Absent or Incomplete Flavor Impact Studies

Longitudinal and Switching Efficacy Studies

In mid-2021, the FDA rejected PMTA applications for millions of flavored e-liquids on the basis that these applications lack sufficient evidence demonstrating that the flavored ENDS products will provide a benefit to adult users that would be adequate to outweigh the risks to youth. In recent Market Denial Orders issued by FDA, the Agency clarified simply following the minimum requirements for submission would not be enough, and that to achieve market authorization applicants must provide data from Randomized Control Trials and/or Longitudinal Cohort Studies that measure the effectiveness of these products over an extended period of time. In addition, the Agency has asked for a comparative efficacy measurement that addresses the increased effectiveness of ENDS products that use flavors other than tobacco to demonstrate those products’ benefits to adult users outweigh the risk of youth uptake.

At Accorto Regulatory Solutions, we have collaborated with one of the worlds’ leading Consumer Research Organizations to develop a series of studies which provide clear data demonstrating the effectiveness of ENDS products in assisting adult smokers in transitioning away from combustible cigarettes and meet the Agency’s current requirements.

Our Study Includes

• Randomized Control Study
• Quitters/Switchers Survey
• Flavor Ban Study
• Product Attraction Study
• Longitudinal Cohort Study
• Bridging

Contact us today to discuss conducting longitudinal and switching efficacy studies for your brand and how we can manage the amendment of your current application to include data from these studies in your current in-process application.

Deficiency Letter Response

Deficiency letters, the FDA’s formal request for additional information they need to complete the review process of an application, is a critical step in the Substantive Scientific Review phase of the PMTA process. Applicants typically have 90 days to address any deficiencies identified and provide additional data to supplement informational gaps. Applicants that fail to address these deficiencies properly are likely to receive a Marketing Denial Order (MDO) for their application.

Pre-Deficiency Letter Strategy

Is your application in review but has not yet received a deficiency letter? Now is the best time to act. Our team of experts will conduct a gap analysis on your existing application and identify possible areas of deficiency prior to receiving your letter from the FDA. By addressing deficiencies early, our team will have the time to perform supplemental studies to fortify your application, giving you the best chance at achieving market authorization.

Post-Deficiency Letter Response

Already received a letter from the FDA? Don’t wait! Applicants that fail to properly address deficiencies are likely to receive a Marketing Denial Order (MDO) for their application and be removed from market. Contact our dedicated regulatory support staff today to review your deficiency letter and develop a comprehensive strategy to best address your application deficiencies within the response window. · For more information on Deficiency Letters, view our article: The FDA Deficiency Letter Response Process for Premarket Tobacco Applications: How to Survive Substantive Scientific Review

Additional Servies

Administrative Services

• eCTD & eTTD Formatting
• Cover Letter
• FDA Reviewers Guide
• Integrated Summary
• Letters of Authorization
• Environmental Assessment
• Hyperlinking

Clinical Services

• Pharmacokinetic (PK) Studies
• Abuse Liability
• Puff Topography
• Biomarker Assessment

Perception & Intent Services

• Qualitative Study
• Quantitative Study
• Human Factor Study
• Marketing Plan Development
• Literature Review
• Label Compliance

Chemistry, Manufacturing, and Controls (CMC) Services

• Tobacco Product Master File (TPMF)
• Cover Letter Development
• Reviewers Guide
• Integrated Summary
• Letters of Authorization
• Environmental Assessment
• Hyperlinking

Non-Clinical Services

• Harmful and Potentially Harmful Constituents (HPHC) Testing
• Toxicology
• Stability
• Literature Review

Training Services

• Training for FDA Inspections

Our team is proud to offer a wide range of high-quality regulatory and scientific services to support your product’s premarket applications for the Food and Drug Administration (FDA). If you are looking for assistance in any of the areas above, contact us today and consult with our team on how Accorto Regulatory Solutions can help you.