Pod-based ENDS device PMTA assessments
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
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
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
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
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.