In the Next Generation Nicotine Delivery Products (NGPs) 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 NGPs. Broughton Nicotine Services provide toxicological strategies and services to support manufacturers in the following key areas:
Toxicological studies involve a tiered approach of data gathering and risk assessment depending upon the product. The ultimate objective is to develop an informed and scientifically justified assessment of the risk to health presented by a 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 a product.
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 nicotine delivery medium is an important part of a regulatory dossier.
Broughton Nicotine Services In vitro testing services include:
Our team of experienced toxicologists will design and manage your studies to comply with regulations including US PMTA and 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 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 NGP sector. This full-service 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.