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.
ISO 18562 evaluation of a medical device in contact with the breathing gas pathway
As part of a large programme of work in evaluating the safety of a new endotracheal tube device, bibra was asked to evaluate the health risks posed by exposure to potentially hazardous substances that may be transferred to the patient via the gas stream during device use.
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.
Registration of a novel biocidal active substance
EU manufacturers of biocidal products are required, under the Biocidal Products Regulation (BPR), to submit a dossier of information to the European Chemicals Agency (ECHA). Before a biocidal product can be registered, however, the active substance must also be approved by the Agency.
Updating REACH dossiers following ECHA Evaluation decisions
Manufacturers of chemicals in, or importers into, the European Union are required under the REACH regulation to submit a dossier of information on their substances to the European Chemicals Agency (ECHA). The Agency can, after evaluating the information provided by the registrant, require the company to update or amend their dossier, including with the addition of new experimental data. This is called a “Compliance Check decision”
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).
Δ9-THC – a low-level impurity in food
The client identified a potential contamination risk in certain of their (non-cannabinoid) food products. Low levels of (-)-trans-delta-9-tetrahydrocannabinol (Δ9-THC) – the main psychoactive component of cannabis – were analytically determined in several foodstuffs, from a specific production line.
Literature review and in silico prediction of metabolites
As part of their overall regulatory requirements, the client was asked to provide information on the known or predicted metabolites of a number of ingredients in their products. This formed part of a broader programme of work that bibra conducted for this client.
In silico prediction of genotoxicity and carcinogenicity
As part of their overall regulatory requirements, the client was asked to provide an assessment of the known or predicted genotoxicity and carcinogenicity of a number of ingredients in their products. Bibra were provided with a list of several substances and asked to carry out this work following the genetic toxicology in silico (GIST) protocol.
In silico assessment of impurities in a pharmaceutical
The client presented us with the structures of a number of impurities in a medicine currently in development for advanced cancer indications.