Sponsorship & Exhibition Opportunities

Sponsorship opportunities available

Sponsoring the Extractables & Leachables conferences is the perfect opportunity to get your company in front of the people who count, generate new business leads in the process and nurture those all important relationships.

Contact Stephen Frier on +44 (0) 1372 802006 or at sfrier@smithers.com to start discussing your bespoke package today.

Alternatively, schedule a meeting with Stephen here >>

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E-L-EU-2025-SPEX-Brochure_2

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2025 Sponsors

Chorley Consulting

https://chorleyconsulting.co.uk

Chorley Consulting are an independent toxicology consultancy based in the UK. We specialise in designing and delivering ISO 10993 compliant safety assessment programmes for medical devices. We offer expertise in:

Biological evaluation of medical devices
Study management of biocompatibility and E&L studies
Toxicological risk assessment of E&L substances
QSAR analysis

We work with clients ranging from multinational device manufacturers to start-ups and have experience with assessing the biological safety of a wide range of device types. Our biological evaluation plans and reports have formed part of submissions to notified bodies and authorities as well as supporting clinical trial applications.

Chorley Consulting works to a comprehensive quality management system and are certified to ISO 9001. We employ a team of experienced safety assessors, including a number of UK/European registered toxicologists. As such, we ensure the knowledge of an experienced team goes into delivering every assessment.

Eurofins BioPharma Product Testing

https://www.eurofins.com/biopharma-services/product-testing/services/biopharma-product-testing-services/quality-control/packaging-testing/extractables-and-leachables-testing/

Whether you are evaluating pharmaceutical manufacturing equipment (such as single-use systems), container closure systems, delivery devices, or other medical devices, Eurofins BioPharma Product Testing network of laboratories offer a broad range of services to support extractables and leachables testing. With over 20 years of experience and over 100 scientists dedicated to E&L testing, we conduct hundreds of controlled extraction studies each year, along with the associated leachables stability studies.

We offer a variety of controlled extraction techniques to generate an extractable profile that will best match the intended use of the components being evaluated. In addition, we conduct simulated and real-time leachables studies to evaluate the presence of leachable compounds in the drug product. Our toxicologists can then evaluate the E&L data to determine the impact to patient safety. We can use our extensive experience to successfully develop and validate fully GMP-compliant methods to monitor leachables in your drug product or intermediates.

GBA Group

https://www.gba-group.com

GBA Pharma operates from two GMP-certified, FDA-inspected labs in southern Germany, specializing in pharmaceutical, biotherapeutic, and medical device analysis. With 170+ experts and decades of experience, GBA provides quality control, method development, raw material testing, stability studies, microbiological analysis, and regulatory support—ensuring compliance and quality throughout the product lifecycle for global clients.

In our qualified laboratory the relevant expert knowledge is available and we guarantee that your E&L study is thoroughly planned, the appropriate methods are competently chosen and the experimental phase is carried out by experienced and well-trained staff. Our Customers outsource each step to GBA and our senior regulatory affairs experts along with our highly experienced and qualified E&L experts team support at each step:

i) Planning and Risk Assessment
ii) Extractables Study
iii) Toxicological Assessment
iv) Leachables Study

Make use of GBA’s services and experience in case of the complete qualification of a packaging material, the identification of leachables, the response to a letter of deficiency, and many more.

Knoell

https://www.knoell.com

knoell is a full-service partner supporting your product registration and regulatory compliance needs—from planning through market launch and beyond. Since 1996, we've been active across global sectors such as animal health, biocides, chemicals, cosmetics, crop protection, food products, and increasingly, medical devices. In this area, we provide expert guidance on biological safety, including the development of ISO 10993-compliant biological evaluation plans, study monitoring, toxicological risk assessments, and zoonosis risk assessments. Our in-house experts in toxicology, analytical chemistry, and regulatory science ensure your medical device complies with regional and international requirements, including those of the FDA, EU notified bodies, and MHRA. With operations across Europe, Asia, and North America and a global network of partners, we offer local insight and global reach. knoell: your trusted partner for regulatory success in every market.

Lhasa Limited

https://www.lhasalimited.org/

Lhasa Limited is a not-for-profit organisation driven by a clear purpose: To enable informed decision-making on chemical safety. We create cutting-edge software solutions that address real-world chemical safety assessment challenges, including supporting the extractables and leachables (E&L) risk assessment workflow—from the introduction of E&Ls through to safety assessment, leveraging a read-across approach. Designed by scientists, for scientists, and developed in collaboration with industry stakeholders and regulators, our technology empowers scientists to make better predictions on the safety of drugs, chemicals, and cosmetics. By utilising existing data more effectively and advancing computer-aided reasoning systems, we are committed to driving scientific progress and improving chemical safety worldwide.

Mérieux NutriSciences

https://www.merieuxnutrisciences.com/

Mérieux NutriSciences | Pharma & HealthCare is a valued partner to the global pharmaceutical industry. We offer a complete range of analytical and research services for APIs and pharmaceuticals, including safety and quality controls, development and validation of analytical methods. Investigation studies and contract research services are provided according to customer specifications. The dedicated GMP/GLP area of about 2800 sqm, with four independent labs and extensive storage capacity, ensures comprehensive and reliable testing solutions.
As part of our ongoing commitment to scientific innovation and regulatory advancements, we actively contribute to industry discussions. In this context, we will be presenting an expert talk on the analytical challenges of PFAS in chemical characterization. PFAS, widely used across industries for their unique properties, are under increasing regulatory scrutiny due to their persistence and potential health risks. Given their relevance in medical devices, a simple screening approach may not be sufficient. A more targeted investigation within biocompatibility assessments is becoming essential to ensure compliance and safety.

Mérieux NutriSciences | Pharma & HealthCare continues to support the pharmaceutical and healthcare industries by addressing emerging analytical challenges with cutting-edge expertise and regulatory foresight

Rubber Consultants

Established in 1984, Rubber Consultants provides consulting, testing, and R&D services for the rubber, polymer, and elastomer industries. As the consultancy unit of the Tun Abdul Razak Research Centre (TARRC), we bring over 40 years of expertise to businesses worldwide, enhancing their products and processes.
We offer comprehensive extractables and leachables (E&L) testing to ensure the safety and quality of pharmaceutical, healthcare, and packaging products. Our services cover orally inhaled and nasal drug products (OINDPs), such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs), as well as parenteral and ophthalmic drug products (PODPs), including prefilled syringes, bags, tubing, vials, filters, closures, and bottles. Our E&L testing is carried out to the Product Quality Research Institute (PQRI) Safety Thresholds and Best Practices for Extractables and Leachables in OINDPs.
Committed to regulatory excellence, we are ISO 9001:2015 certified, ISO/IEC 17025:2017 accredited, and compliant with FDA regulations, ensuring the highest standards in pharmaceutical testing and analysis.

Nelson Labs

https://www.nelsonlabs.com/

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,800 customers across 14 facilities in the United States, Mexico, Asia and Europe. We have a comprehensive array of over 800 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues. Learn more about Nelson Labs at www.nelsonlabs.com
Safeguarding Global health - with every test we complete.

SafeBridge

https://www.trinityconsultants.com/safebridge-regulatory-life-sciences-group

SafeBridge is the premier resource for high-level safety and health consulting to the pharmaceutical and biotechnology industry. Founded in 1997, the team includes more than 50 professionals who provide the Potent Compound Safety Triangle® of services, namely, toxicology, industrial hygiene, and industrial hygiene analytical chemistry. Our specific expertise is in the recognition, evaluation, and control of potential worker exposure and product safety issues associated with the handling of potent and highly potent drug substances and drug products. In addition to the work we have traditionally performed for the pharmaceutical industry, we also provide services related to the registration and approval of food and beverage ingredients and biocides, general industry industrial hygiene services, and quality assurance of non-clinical toxicology studies

Safetree Consulting

https://www.safetree.at/

Safetree Consulting e.U. is a consultancy office located in Vienna, Austria. The firm was founded in 2018 by Reinhard Stidl. Dr. Stidl is a trained (MAS(Toxicology), Dr.rer.nat) and certified (TRISK and ERT) toxicologist specialized in toxicological risk assessment of chemicals in pharmaceuticals and medical devices, for example on active ingredients (due diligence evaluations, carry over PDEs, occupational safety), excipients (supporting formulation development), and a variety of impurities/contaminations (mutagenic impurities, solvents, elementals, nitrosamines, extractables and leachables, particles, accidental contaminations). Specifically safety evaluations of extractables and leachables in pharmaceuticals and chemical constituents from medical devices became a strong focus. Safetree Consulting provides solutions for the current challenges related to the safety assessment of E&L and medical device constituents, coming from a continuously changing regulatory environment, involvement of innovative in silico tools and databases, and drives scientific and effective conclusions on product safety.

SCIEX

https://sciex.com/

Advances in human wellness depend on the power of precise science.
At SCIEX, our mission is to deliver solutions for the precision detection and quantification of molecules, empowering our customers to protect and advance the wellness and safety of all.
SCIEX has led the field of mass spectrometry for 50 years. From the moment we launched the first ever commercially successful triple quad in 1981, we have developed groundbreaking technologies and solutions that influence life-changing research and outcomes.
Today we continue to pioneer robust solutions in mass spectrometry and capillary electrophoresis. But we don’t just develop products. It is what we do together with our customers that sets us apart. That’s why thousands of life science experts around the world choose SCIEX to get the answers they can trust to better inform critical decisions. Decisions that positively impact lives.
We proudly stand behind our tagline: The Power of Precision.

SGS

https://www.sgsgroup.de/en

We are SGS – the world’s leading testing, inspection and certification company. Our global network of industry experts offers a full range of state-of-the-art GMP pharmaceutical testing solutions (microbial and physical-chemical labs) that are aligned to the latest international regulatory standards in support of small and large drug product manufacture. We draw on decades of experience in testing, inspection and certification to help deliver safe and high-quality products to the consumer.

Smithers

https://www.smithers.com

Smithers helps medical device and pharmaceutical product manufacturers bring innovative and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA.

Our experienced team will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO.

We can assist throughout your medical device product development.

Services include:

Extractables and leachables studies
Device physical and functional testing
Device verification and validation
Product and packaging durability, integrity and stability testing
Material selection, property characterisation, life prediction
Failure analysis

Contact us

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