Broughton

Company Description: Broughton is a Contract Research Organisation (CRO) with over 10 years’ experience delivering analytical, scientific and regulatory services for the ENDS industry. Our team of scientists, toxicologists and regulatory experts are generating data and managing client projects in areas including US PMTA strategy and delivery, EU TPD submissions and Medicinal Product strategy and applications. Our 20,000ft² CRO facility in the UK incorporates several specialist laboratories equipped with the latest aerosol collection instruments, high-spec analytical equipment and fully validated data management systems.

Company Website: http://www.broughton-group.com

CSUR

Company Description: CSUR is a multi-disciplinary research agency providing behavioural science support to companies submitting applications for PMTA, MRTP and TPD approval. In seeking regulatory approval for their products ENDS companies are required to support an extensive programme of research encompassing laboratory, clinical and behavioural studies. In relation to behavioural studies the need is to undertake research to identify the prevalence of use and intentions to use across diverse population groups including, adults and young people and amongst current, former and never smokers. Research is required to assess the impact of ENDS use to identify whether such use results in an increased or decreased likelihood of smoking. Research is also required to gage perception of ENDS amongst current, former and never smokers and in both adults and youth, CSUR has expertise in conducting behavioural studies across all of these areas.

Company Website: http://www.csures.com/index.php/our-research/

TFN

Company Description: Next Generation Labs (NGL) has been the innovator in synthetic nicotine development since 2014 and has led the advance in the use of synthetic nicotine that now offers adult consumers access to nicotine that is free of all tobacco-derived constituents, contaminants and residuals. NGL developed the first bulk patented manufacturing process for high quality pure synthetic nicotine sold under the brand name TFN and Pharmanic for the tobacco, vape and pharmaceutical industries. The company has both patented and proprietary methods for producing R-S, R and S-form isomer synthetic nicotine. NGL is the global leader in bulk synthetic nicotine manufacture, product development and product testing protocols. NGL's TFN branded S and R-S and R nicotine isomers have become industry standards for brand manufacturers of vape, oral nicotine and heat not burn products worldwide. NGL currently holds a number of worldwide process and methods patents for the manufacture of synthetic nicotine and the use of R and S isomer nicotine combinations in smoking cessation products. http://www.nextgenerationlabs.com/

Company Website:

ExtLe Solutions

Company Website: http://extlesolutions.com/

Enthalpy Analytical

Company Website: enthalpy.com

Keller and Heckman

Company Description: Keller and Heckman is the premier law firm servicing the global regulatory, public policy, and litigation needs for the Tobacco and E-Vapor industry. Our decades of comprehensive and extensive experience dealing with the regulation of food, supplements, drugs, and medical devices before regulatory agencies such as the U.S. Food and Drug Administration (FDA), as well as international regulatory authorities, uniquely positions us to guide companies through the myriad of federal, state and international requirements for tobacco, nicotine and related products (including cannabis, hemp and CBD). We advise businesses on all levels of the tobacco, e-vapor, and vaping supply chain, including ingredient and component suppliers, finished product manufacturers, distributors, wholesalers, and retailers.

Company Website: http://www.khlaw.com/index.aspx

RELX International

Company Website: http://www.relxnow.com/

Consilium Sciences

Company Description:

Consilium supports numerous clients as they prepare for Premarket Tobacco Product Application (PMTA), Substantial Equivalence (SE), and Tobacco Product Masterfile (TPMF) submittals. Consilium offers scientific and strategic regulatory support by guiding clients through every step of the complex tobacco regulatory process including designing regulatory-facing studies or submitting regulatory applications. We are well versed in all areas of tobacco regulatory including administrative, integrated summary, chemistry, manufacturing, and control (CMC), nonclinical studies, clinical individual studies, clinical population studies, and enviornmental assessments, as well as compiling all information and studies of a PMTA into the seven modules of the electronic tobacco technical document (eTTD) format.

Consilium employs a core group of full-time, senior-level Principal Scientists, combined with the broader Consilium Scientific Network of more than 300 consultants from across the globe. This unique distributed-consulting approach allows us to build cost-efficient, project-specific teams that solve our clients’ needs quickly and effectively. Typically, a Consilium project team will have one or more of our full-time consultants leading the project. Our teams are custom-built and project-specific, ranging in size from one individual up to a 40-person team. At Consilium, we present goals, explain requirements, embark on study design, conduct research, develop strategy, and prepare complete regulatory submissions. Consilium also supports clients beyond submission with follow-up correspondence, responses to deficiency letters, post-market surveillance, and design and execution of annual reporting requirements.

Company Website: www.consiliumsciences.com

High Point Clinical Trials Center

Company Description: High Point Clinical Trials Center has provided comprehensive (Phase I-III) clinical site services since 2008.  Our 42,000 ft2 facility consists of three unique units for the execution of outpatient and inpatient clinical studies. In addition to healthy normal Phase I studies, we focus on specialty populations such as Metabolic Diseases, Respiratory, CNS, Cardiovascular and Nicotine-related.

Company Website: www.hpctrialscenter.com