Element Materials Technology has unveiled an exciting new global offering of Extractables and Leachables (E&L) services, combining the expertise of over 75 professionals across its labs in Ann Arbour and Bend in the US, Toronto in Canada, and Manchester in the UK. This enhanced offering of Testing, Inspection, and Certification (TIC) services is a result of Element’s recent acquisitions of Avomeen, Hall Analytical, and VR Analytical.
Regulatory agencies are becoming increasingly strict in their requirements for E&L studies before drugs and products are approved for market. These studies are crucial to ensuring the safety of drug products and that their efficacy is not compromised by the presence of extractable and leachable substances. It is essential that these substances are evaluated during the drug development process to guarantee the safety of patients and the effectiveness of the drug.
Element is proud to announce the promotion of Sarah Brophy to the role of Global Scientific Director for Extractables and Leachables in the Life Sciences Business Unit. In this newly created position, Sarah will be responsible for driving the successful delivery of Element’s strategy, operations and analytical services related to E&L.
This includes the management of Element’s E&L technical programs and global projects, as well as ensuring the achievement of the strategic and technical objectives of the Life Sciences Business Unit.
Element’s expertise in rigorous testing for Extractables and Leachables (E&L) on a wide range of products across the world’s regulatory authorities has established the company as an unparalleled global provider of medical product testing, storage, and delivery services.
Led by Global Scientific Director Sarah Brophy, the team is well-equipped to meet the ever-growing demands of the regulatory approval process and help companies bring drugs and products to market with speed and efficiency.
At Element Life Sciences, we are dedicated to helping the world’s leading healthcare brands bring safe and effective products to market. Our tailored E&L studies cover pharmaceutical, biologic, medical device, and combination products.
Our team of scientific experts have the knowledge and expertise to evaluate the safety of materials across administration, formulation, dosage, container-closure systems, and drug delivery device requirements, so you can be sure that the products you create are safe and can reach consumers quickly.
Element’s Life Sciences division is a global powerhouse of scientific expertise, with a network of labs housing more than 1,400 chemists, technologists, and scientists. Our comprehensive scientific solutions offer customers a full-service product development lifecycle, from early R&D through complicated regulatory approval processes and beyond. We offer the experience and capabilities to ensure the success of your project from start to finish.
About Element
Element Materials Technology Group is an industry leader in providing innovative and reliable testing, inspection, and certification services that guarantee the safety and sustainability of a wide range of products, materials, and technologies.
With a team of over 9,000 scientists, engineers, and technologists, and a network of more than 270 laboratories worldwide, Element helps customers move from early research and development to complex regulatory approvals and into production with confidence. In an age where failure is not an option, Element Materials Technology Group is the go-to choice for reliable quality assurance.
Element has achieved the highest ESG ranking in the testing, inspection and certification industry and secured a spot in the top 150 companies in the world, according to Sustainalytics, a global leader in ESG research and data.
Its environmental commitments are unparalleled, having adopted science-based targets and committing to reaching net zero emissions across its entire global business by 2035. This is an incredible feat and shows the company’s commitment to creating a more sustainable future.