Broughton Nicotine Services is focused on the development of innovative scientific programs to deliver quality and regulatory compliance for the companies we work with.
Our team have a successful track record of engagement with both the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK and the Food & Drug Administration (FDA) in the US, on scientific programs for Electronic Nicotine Delivery Systems (ENDS). This includes both the generation of scientific data required for pre-market authorization, and on-going Quality Control (QC) services throughout commercialization.
At the core of our business operations, maintaining an inherent culture of quality is key to our commitment to clients. Regulatory agencies expect ENDS businesses to be proactive in their efforts towards the development and manufacture of consistently safe products. Our history of quality compliance with global regulatory bodies enables us to add value to ENDS businesses throughout their supply chain operations.
Broughton Nicotine Services is a member of the UK GLP (Good Laboratory Practice) compliance monitoring programme and we are therefore regularly inspected by the MHRA. Our sister company within the Broughton Group also operates to the UK GMP (Good Manufacturing Practice) standard, and is inspected by both the MHRA and FDA.
We operate in accordance with the International Standard ISO 17025:2017.
Our culture is open and honest and we welcome client audits as a valuable continuous improvement activity.
We are focused on developing strategic partnerships and delivering effective quality management to our clients. Client confidentiality is a key part of our quality system.
Our team are experienced in compiling Tobacco Product Master Files (TPMFs) to support submissions to the FDA.