Developing combination products is a series of challenges. Teams working on these therapeutics and diagnostics need to manage the complexity of overlapping regulations, integrate multiple components safely, and meet global standards, all while navigating resource constraints and tight timelines. Whether it’s harmonising USP and ISO requirements, preparing for regulatory feedback loops, or validating extraction methods, the path to market is rarely straightforward.

Our experts within Eurofins Medical Device Services network of laboratories understand the pressures faced by manufacturers of combination products. That’s why our global testing network is built around the specific needs of developers navigating the intersections of drug, biologic, and device development. Whether you're launching an insulin pen, a prefilled syringe, or a drug-eluting stent or lens, we have the scientific insight and technical capability needed to move you forward.

Our combination product services are designed to meet the highest global regulatory expectations, including those from the FDA, EMA, and under MDR.

With proven expertise in method development and validation, our complete extractables and leachables (E&L) testing (operating under both USP and ISO frameworks) ensure alignment with your specific materials and regulatory strategy.

Our testing programmes evaluate solvent compatibility, temperature, and duration parameters to reflect real-world conditions and ensure accurate risk assessments.

As your partner, we harmonise diverse regulatory standards into one coherent strategy. From toxicological assessments to container closure integrity and glide force testing, our scientists support you at every stage, from design and development through to submission and approval.

Our Combination Products Testing Services include:

• Extractables and leachables testing across drug, biologic, and device interfaces
• Analytical method qualification and validation
• Material characterisation and biocompatibility assessments
• Container closure integrity testing (CCIT)
• Syringe break loose and glide force testing
• Risk assessments tailored to manufacturing processes and product design

Eurofins MDS network of laboratories provides multidisciplinary expertise, GMP-accredited laboratories, and a global team of toxicologists, chemists, and regulatory consultants, all with the knowledge required to help you bring your combination products to market with the minimum of delays.