In the Electronic Nicotine Delivery Systems (ENDS) sector, toxicology plays an important role in both new product development, ongoing product stewardship of commercial products and regulatory submissions to demonstrate the acceptability, safety and compliance of a particular product.
Toxicological studies aid the design, development, modification, stewardship and authorization of ENDS products. Broughton Nicotine Services provide toxicological strategies and services to support ENDS manufacturers in the following key areas:
Toxicological studies involve a tiered approach of data gathering and risk assessment depending upon the ENDS product. The ultimate objective is to develop an informed and scientifically justified assessment of the risk to health presented by an ENDS product. This involves considering the nature of any hazard presented by an ingredient, exposure levels and the dose response, which collectively enable risk characterization.
Desk based toxicology services.
Evaluating the potential health risks associated with exposure to contaminants or other residues in an Electronic Nicotine Delivery Systems (ENDS).
Broughton Nicotine Services Risk Assessments include:
Gathering regulatory in vitro toxicity data through designed experimental toxicology studies to determine the effect of a chemical substance or the whole aerosol is an important part of an ENDS scientific dossier.
Broughton Nicotine Services In vitro testing services include:
Our team of experienced toxicologists will design and manage your studies to comply with ENDS regulations including US PMTA and EU Medicinal Products. Broughton Nicotine Services is a Good Laboratory Practice (GLP) certified Contract Research Organization (CRO) facility for in vitro toxicity services.
Toxicological studies will often include a tailored mix of different types of studies according to regulatory and/or product development requirements.
Broughton Nicotine Services has developed a custom database, named ToxHQ, designed to store critical safety information on ENDS products and their ingredients.
Broughton Nicotine Services offer a wide range of toxicology services, combined with a network of internal experts and partners, exclusively dedicated to supporting companies operating in the ENDS sector. This full-service, when integrated with our other ENDS-focused analytical and scientific services provided, supports regulatory submissions and enables new product development to advance a smoke free future.
Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.
Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.