Pod-based ENDS device PMTA assessments
Case study
As part of a Premarket Tobacco Product Application (PMTA) for a pod-based ENDS device, bibra was asked to provide support preparing non-clinical and human health impact assessments.
Health risk assessments relating to the excipient components of the Voke® formulation
Case study
A novel nicotine replacement device was designed to deliver a pressurised nicotine formulation via a breath operated valve in a cigarette sized medical device. Kind Consumer received a Marketing Authorisation for its lead product, Voke®, in September 2014.
Cannabinoids – preparation of several inhalation focused toxicity profiles
Case study
The client requested the production of a series of urgent toxicity profiles for more than a dozen different cannabinoids, to support and inform their Research & Development (R&D) of new inhalable (non nicotine) consumer products (including their possible incorporation as ingredients into e liquids).
Evaluating the health risks posed by extractables and leachables from an ENDS device
Case study
In order to market their latest product in the United States, the client was intending to submit a Premarket Tobacco Product Application (PMTA) for a pod-based ENDS device.
Hazard characterisation of several e-liquid ingredients
Case study
The client is required to provide regulatory authorities with up-to-date toxicological information related to the ingredients used in their products. Bibra were provided with a list of several substances and asked to produce a hazard review (considering the requirements of the European Tobacco Products Directive, TPD2) for each.