Broughton Nicotine Services has made three senior appointments and completed investments totaling more than £10 million ($12.27 million) into people, facilities, equipment, software development and quality standard certification.
Fozia Saleem has joined Broughton Nicotine Services as director of scientific affairs and program management. Saleem will be responsible for leading pre-market tobacco applications (PMTA) for e-cigarette companies seeking regulatory approval for their products.
Toxicology expert Louise Neilsen has been appointed as a principal scientist and will lead the non-clinical elements of regulatory applications for companies in U.S. and U.K. markets.
Leon Birch has become the new head of scientific development. He will lead a team of development scientists and analytical experts focused exclusively on advancing scientific methodologies for the analysis of ENDS.
In January 2019, Broughton Nicotine Services opened a new contract research organization facility at its Lancashire. U.K. headquarters; in March, the site achieved GLP certification. Defining a set of quality standards for study conduct, data collection, and results reporting, the certification provides reassurance to Broughton’s clients that studies it conducts can be completed for PMTA and Medicinal Product submissions.
In response to announcements in July that the U.S. Food and Drug Administration (FDA) would be implementing changes to ENDS testing requirements for the PMTA regulatory process, Broughton Nicotine Services also developed and validated innovative harmful and potentially harmful constituent (HPHC) testing methods, adhering to ISO 17025 standards and in line with the low limit of detection/limit of quantification levels required for precise toxicology assessments of the new FDA list of 33 analytes.
Broughton Nicotine Services has also invested into high quality equipment and services for its facility. First, into the bespoke LIMS software system, LabHQ Link, which has been deployed to enable direct capture of test data from analytical equipment, reinforcing data integrity for all Broughton’s clients. And second, into high specification analytical equipment for use in Broughton’s specialist laboratories.
“We have seen rapid change over recent months within the reduced-risk nicotine products market, and we are committed to supporting this evolving industry towards creating a smoke-free future,” said Broughton CEO Paul Moran.
“Fozia, Louise and Leon will be great additions to the Broughton team as we continue to pursue new innovations and scientific advancements to help clients achieve success and remain at the forefront of ENDS regulatory compliance.’’