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.