Jim Solyst is the Vice President of Federal Government Affairs with Swedish Match North America. He has held senior positions in Washington DC based companies and associations, including the National Governors’ Association, American Chemistry Council, and the consulting firm ENVIRON International Corporation. During his over 30 years in Washington he has worked closely with federal agencies, including EPA, FDA and OMB. He has also worked with international organizations, including the UN, WHO and OECD.

Mr. Solyst is a member of the Food Drug Law Institute (FDLI) Tobacco Committee as well as the American Chemical Society Committee on Environmental Improvement. He is also a member of the National Academy of Sciences (NAS) Chemical Sciences Roundtable and served on the NAS Committee on Promoting Safe and Secure Chemical Management in Developing Countries. He also serves as an External Affiliate to the Johns Hopkins Risk Sciences and Public Policy Institute.

Mr. Solyst has written several articles and given numerous presentations on a range of regulatory science and public policy issues.

Kevin Burd is the CEO of North America Nicotine (NAN) who exclusively distribute CNT Nicotine for North America. CNT Nicotine is the only nicotine manufacturer to carry 100% of the FDA approved products in the Pharmaceutical category with their impressive Drug Master File (DMF). Besides NAN, Kevin is the co-founder of Chemular, a regulatory consultancy dedicated to tobacco product compliance and registrations for North America and the EU. Chemular has registered several thousand products in Europe and has been progressing several US PMTA applications for the past several years. The company has an impressive world class team including ex-FDA officers and regulatory professionals from the Tobacco and Pharmaceutical industry.

Kevin has worked in the Ecig/Tobacco category for the past 7 years including consulting for top brands and manufacturers. Previously Kevin worked for the Medical Device and Pharmaceutical industry in executive, regulatory, and operations since 1994 for Baxter Healthcare and Mentor Biopolymers (now part of Johnson & Johnson).

Bryan devotes his practice to representing businesses in disputes and regulatory compliance matters initiated by governmental agencies, including by state attorney general, and in other commercial litigation.

Bryan is an accomplished trial lawyer who has served as lead counsel in state and federal courts across the country.

A principal focus of Bryan’s practice is leading the firm's Tobacco practice in which he and other tobacco lawyers represent tobacco manufacturers, distributors, retailers and suppliers in all aspects of their businesses, including regulatory compliance, FDA requirements, administrative disputes involving a federal or state governmental entity, commercial agreements and tobacco taxation matters.

Dr. Samina Qureshi is a highly accomplished and progress-focused professional with more than 13 years of experience in managing, directing and serving as subject matter expert in critical health and pharmacovigilance projects for federal and commercial entities in the US and additional 8 years abroad. She is a physician and also has a Masters in Regulatory Science from Johns Hopkins University.

Currently Dr. Qureshi serves a leadership role at PSI International as Vice President of the Health Sciences Division with projects involving a mix of health sciences, technology, and social services expertise/guidance. She has experience with the premarket tobacco application (PMTA) and the modified risk tobacco product (MRTP) application pathway and developing guidelines for adverse experiences with tobacco products. She counsels clients on developing policies to confirm adherence to applicable regulations, provides compliance and implementation support for clients on emerging FDA CTP regulations, guidance and trends. Her expertise includes health sciences terminology and latest FDA drug safety protocols as well as Medical Dictionary for Regulatory Activities (MedDRA), World Health Organization Drug Dictionary (WHO-DD), and International Classification of Disease (ICD-9/10).

Dr. Qureshi is a published author in numerous journals and invited presenter at international conferences. Demonstrated strengths in program development and supervision, client relations and support, and strategic planning.

Steve’s career spans almost 30 years in FDA-regulated industry in writing and project leadership roles. For the past 3 years this has included MRTPA and PMTA submissions. Key areas of his PMTA support include the steps needed to assemble the diverse set of required documentation, and then melding that with the company’s expertise into a coherent set of summaries, to produce a compliant submission that supports the authorization of the product.

Synchrogenix teams of experts provide a full range of regulatory and document-related services, including submission planning and management, QMS/SOP support, review of documentation and authoring of summaries across CMC, Nonclinical, and Clinical, Literature search and review, and Publishing and Submission of the full hyperlinked PMTA or MRTPA to CTP.