Who Is Chemular?
Chemular is a specialized FDA regulatory consultancy, founded in 2015 by experts in nicotine and U.S. FDA compliance
Real-life strategy to reach your goals.
About Chemular, Inc.
Chemular is a specialized FDA regulatory consultancy, founded in 2015 by experts in nicotine and U.S. FDA compliance, dedicated to helping companies navigate the complex regulatory landscape for tobacco, nicotine, and related products. With over a decade of industry experience, we provide expert guidance on Premarket Tobacco Applications (PMTAs) and other regulatory submissions. Our approach combines deep knowledge of FDA requirements with practical, results-driven strategies to help clients meet regulatory benchmarks efficiently and effectively.
Our specialists manage every aspect of FDA submissions from end to end. Each project is rigorously prepared for regulatory review, with compliance and attention to detail prioritized at every stage. Chemular offers comprehensive compliance services, including full PMTA support, quality and manufacturing systems readiness, tax compliance services, and strategic guidance on U.S. market entry. Its capabilities span product testing coordination, document preparation, data analysis, regulatory submissions, and ongoing FDA engagement. Chemular also provides operational support to align manufacturing practices with federal standards, helping ensure a streamlined path to commercialization. With a team of seasoned toxicologists, chemists, clinical experts, and regulatory strategists, Chemular has successfully submitted PMTAs for over 200 products and continues to guide companies through all phases of the PMTA and MRTP processes.
We offer complete or partial assistance with PMTA submissions, EU TPD fillings, PACT act compliance, SDS sheet creations, regulatory consulting advice and more.
Meet our amazing team
Our team is extremely qualified to help your business grow
Kevin Burd
Chief Executive Officer
Bryan Burd
Chief Operations Officer
Jason Carignan
Chief Commercial Officer
Jesse Maxwell
EVP Sales and Marketing
Manoj Misra, PHD
Sr. Director, Chemistry & Toxicology
Lise Fraissinet, MSC, MBA, PMP
Chief Program Manager
Ed Carmines, PHD
Chief Science Officer
Alan Scott
Program Manager
Bonnie Coffa, PHD, DABT
Regulatory Toxicology Consultant
Karen Goss
PACT & Tax Compliance Specialist
Contact us for a free consultation
Founded in 2015 by industry and FDA experts in nicotine, tobacco, medical devices and compliance, Chemular and its affiliated companies, provide a vertically-integrated suite of regulatory and manufacturing solutions that are unmatched in the market.
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