Owner & Principal Consultant, QualReg Solutions LLC
Former Director of FDA Regulatory Quality Compliance, JUUL Labs
Former FDA Director & Investigator, Office of Regulatory Affairs (ORA), U.S. FDA
Gabriel Muniz is the Owner and Principal Consultant at QualReg Solutions LLC, where he advises tobacco and ENDS manufacturers on regulatory compliance, quality systems, and FDA readiness. With over 15 years of experience spanning federal oversight and private industry leadership, Gabriel offers a uniquely integrated perspective on compliance strategy and operational excellence.
Prior to founding QualReg Solutions, Gabriel held multiple leadership roles at JUUL Labs, including Director of Regulatory Compliance and Quality Systems, where he led ISO certification efforts, managed global supplier quality, and directed eQMS implementations. He was instrumental in building the company’s audit and inspection readiness framework and regulatory submission infrastructure.
Gabriel also served as an Investigator and Director at the U.S. Food and Drug Administration (FDA), where he was the first to lead the Tobacco Operations Staff within the Office of Regulatory Affairs. There, he developed nationwide enforcement strategy, oversaw high-impact inspections, and coordinated regulatory responses tied to the Family Smoking Prevention and Tobacco Control Act.
Gabriel’s expertise spans tobacco, medical devices, biologics, and food safety. He is known for his ability to translate complex regulations into actionable strategies, helping clients achieve both legal compliance and business continuity. From quality systems and document control to supplier audits and FDA communication, Gabriel is a trusted advisor for companies navigating the evolving nicotine delivery landscape.
Julie is the Chief Commercial Office at Deallus, a market leading strategy consultancy, which was acquired by Global Data at the beginning of the year. Julie’s career in life sciences spans 20 years with a focus on partnering with clients on strategy development on local, regional and global level . For more than decade Julie has led large global and regional competitive mindset training programmes for large pharma. Since 2017 Julie has regularly been engaged as an inspirational speaker on Competitive Mindset across brand, portfolio and corporate audiences. Her expertise includes clinical and commercial planning, brand & portfolio strategy as well as advising organisation on personalised healthcare approaches across various disease areas. Julie holds a PhD in Neuroscience from Imperial College London sponsored by Pfizer.
Melis Coraggio is a Consultant in the FDA & Life Science practice group at King & Spalding LLP. She works closely with clients in navigating the pre-market tobacco product application and review processes and advises in the tobacco and nicotine space, including pre-market tobacco product applications (PMTAs), Substantial Equivalence Reports (SEs), Exemption Requests (EXRs), and provides strategies to assist in facilitating stakeholder engagement.
Prior to King & Spalding, Melis was a Regulatory Review Scientist at FDA’s Center for Tobacco Products’ Office of Science from 2015-2023 where she held roles as a Regulatory Health Project Manager and, primarily, as a Chemistry Reviewer. During that time, she was instrumental in drafting the Center’s first published Product Standard to limit the quantity of nicotine in cigarettes and certain other combusted tobacco products. Among her accomplishments, she was involved in drafting of the “Validation and Verification of Analytical Testing Methods Used for Tobacco Products” Guidance which she presented at 2022 Tobacco Science Research Conference to industry and other tobacco stakeholders as well as served on the Q&A panel.
Before joining the tobacco and nicotine space, Melis spent nine years as a Scientific Researcher at Genentech, Inc.’s Division of Drug Metabolism and Pharmacokinetics performing analytical method development, method validation, and quantitative bioanalysis of small molecule pharmaceuticals for drug discovery and development. During her tenure, she specialized in beta testing of new mass spectrometry instrumentation in collaboration with Thermo Fisher Scientific and presented data at various stakeholder meetings.
Melis holds a Master of Science in Biotechnology with a focus in Molecular Biology from Northeastern University and a Bachelor of Science in Biochemistry with a minor in Biological Sciences from the University of Delaware.
David Oliveira is a consultant specializing in government and regulatory affairs. He most recently served as Deputy Director of the Stakeholder Relations Office in the Office of the Center Director, at the Center for Tobacco Products at the FDA. Prior to that, he held two different supervisory positions within the USDA. He also spent over 10 years in the private sector as a government affairs professional where he represented numerous colleges and hospitals, businesses, state agencies, municipalities, and other non-profits. He also worked in the US Congress for seven years, as a staffer in both the House and Senate. He is a graduate of the University of Connecticut School of Law, and of the University of Massachusetts at Amherst.
David is a leading regulatory expert in nicotine-containing products, with over 15 years of experience across the pharmaceutical and tobacco sectors. He played a pivotal role in the approval of e-VOKE, the world’s first medically licensed e-cigarette, and has since been instrumental in shaping regulatory strategies for next-generation nicotine products.
David’s cross-sector expertise spans product development, toxicological assessment, and global regulatory compliance, with a focus on supporting manufacturers through complex submissions such as Premarket Tobacco Product Applications (PMTAs). His multidisciplinary background enables him to bridge scientific, legal, and commercial perspectives in regulatory decision-making.
David holds a BSc. (Hons) in Biochemistry, an LLB in Law, and a Master of Business Administration (MBA). He is a qualified medical toxicologist and a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA).
Jacob Sperry, VP of Customer Experience of Trullion, helps top finance and accounting teams to automate processes. As a seasoned leader in the industry, Jacob previously led the Customer Experience organization at CaptivateIQ, and was a Partner at Connor Group, leading the Salt Lake City office’s Technical Accounting and IPO Services team. Jacob began his accounting career at the Financial Accounting Standard Board, then PwC, and holds a Master of Accountancy from Brigham Young University, and was a licensed CPA in New York.
Sarah has broad experience serving pharma, medical device, and consumer products industries, with a focus on integrating science, quality processes, and business goals in a regulated environment. She has a proven ability to develop resilient, cross-functional teams and champion complex projects across diverse groups of stakeholders. Sarah specializes in helping clients develop and successfully execute strategies to access the U.S. market.
Sarah works closely with clients to plan and submit premarket tobacco product applications (PMTAs) and modified risk tobacco product applications (MRTPAs) across various nicotine product categories, including novel, emerging delivery systems. She combines her extensive industry experience, scientific expertise, and business acumen to navigate the rapidly evolving regulatory landscape and provide practical solutions to regulatory challenges. Sarah supports regulatory strategy across all scientific areas including product design and development, manufacturing, and nonclinical and clinical study programs.
She specializes in helping clients create and navigate multi-product regulatory strategies and product line extensions. These strategies leverage existing scientific evidence through use of supplemental PMTAs (sPMTAs) and tobacco product master files (TPMFs) to minimize regulatory costs and timelines. She also supports preparation for Tobacco Products Scientific Advisory Committee (TPSAC) meetings.
Helen Flanagan is the product lead for EyeQ, Wincanton’s digital transport control tower product. She joined Wincanton in 2023 and plays a key role in the strategic shift in the business to focus on transport services powered by digital technology. Helen brings a depth of experience in logistics operations, sales, solutions design and consulting and has enjoyed varied roles at DHL Supply Chain and Kuehne & Nagel.
