A diversity of clients. An abundance of solutions.
Consilium’s clients range from multi-billion-dollar corporations to smaller, privately held companies. Our recent focus has been supporting clients in preparing numerous Premarket Tobacco Applications (PMTAs) and Substantial Equivalence (SE) applications, as well as rapid turnaround scientific litigation support.
At Consilium we take pride in developing strong relationships with clients and understanding their unique needs so that we can build the right team of scientific experts to develop and implement quality solutions. Our global network of mostly doctoral-level scientists and clinicians includes expertise in nanotechnology, materials characterization, toxicology, pharmacology, epidemiology, chemistry, GMP, consumer research, regulatory engagement, post-market surveillance, literature reviews, statistics and more.
We develop and provide scientific and regulatory solutions and regularly engage with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada.
Consilium’s clients include tobacco, vaping and cannabis organizations ranging from multi-billion-dollar global corporations to smaller,
privately held companies.
Stan Gilliland, PhD, our Materials Science Practice Lead, joins in on the discussion around synthetic nicotine and its regulatory and technical implications. We discuss synthetic nicotine pharmacology and toxicology, synthesis, and its impact on the tobacco industry. We introduce the current regulatory landscape around synthetic nicotine, potential regulatory pathways, and unique challenges.
Contact us for more guidance on this emerging topic.
Consilium’s mission is to be the leading provider of regulatory solutions for materials science, vaping, tobacco and cannabis products. This includes preparation of PMTAs, SEs, MRTPAs and TPMFs as well as other regulatory documents for the FDA, EMA and Health Canada.
Our emphasis is on potentially harm-reduced products.