IMed Consultancy helps companies developing combination medical devices, products that unite drugs, devices, or biologics, to achieve compliance across multiple regulatory frameworks. Whether you’re adapting a drug-device combination product or bringing a new therapy to market, our combination product consultancy guides you through every step with clarity and precision.
Bridging the Gap Between Devices and Pharmaceuticals
Combination products sit at the intersection of medical device and pharmaceutical regulation, and managing that overlap requires specialist cross-functional knowledge. IMed Consultancy supports teams that need to handle both device and drug combination requirements under EU MDR, IVDR, and FDA frameworks.
Our experts identify your product’s primary mode of action and ensure every component meets the right regulatory standard, helping you move forward confidently and compliantly.
Expert Support Through Every Phase
With extensive experience in combination product consulting, IMed Consultancy supports clients from concept to market release. We help you define, document, and demonstrate the safety and performance of your product, all while managing regulatory complexity behind the scenes.
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Understanding Combination Product Regulations
In the EU, combination product regulation depends on the product’s principal intended purpose, whether it’s primarily medicinal with an ancillary device, or vice versa. The FDA takes a similar approach, assigning lead review responsibility to CDER, CBER, or CDRH depending on the product’s makeup.
IMed Consultancy helps you identify your product’s primary mode of action, determine the correct regulatory pathway, and build submission documentation that satisfies device and drug requirements.
Our Combination Products Expert
Caroline Timberlake
Caroline brings over 15 years of experience in the pharmaceutical and medical device industries, with deep expertise in regulatory affairs and quality assurance. At Imed, Caroline leads our consulting services, ensuring clients receive high-quality guidance and support as they navigate complex regulatory requirements.
Why Choose IMed Consultancy?
Our consultants master both sides of the regulatory equation: device and pharma. We’ve supported clients developing delivery systems, drug-eluting stents, prefilled injectors, and other regulated drug–device combination products.
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Frequently Asked Questions
Managing drug-device combination products can be complex. Here are some of the most common questions our clients ask.
A combination product integrates two or more regulated components, such as a drug, device, or biologic, into a single therapeutic solution. Common examples include prefilled syringes, drug-coated implants, drug-eluting stents, and integrated drug delivery systems.
Regulatory classification depends on the product’s primary mode of action. The EU MDR governs device-led products, while the EMA or FDA may lead reviews for drug-led combinations. IMed helps you define the right regulatory route and prepare documentation for both components.
A combination medical device integrates a physical or chemical drug component, while a companion diagnostic identifies which patients will benefit from a particular drug. IMed provides tailored support for both categories.
Yes. IMed Consultancy provides end-to-end support for FDA combination product submissions, including design dossiers, clinical evaluation, and regulatory liaison.
Ideally, as early as possible, preferably during product design and feasibility. Engaging an experienced combination product consultant early helps you select the correct classification, align design documentation, and avoid rework later in development.
Ready to Simplify Combination Product Compliance?
IMed Consultancy helps you turn innovative therapies into compliant, market-ready products. From classification to approval, our combination product consultancy provides the expertise, flexibility, and clarity you need to succeed.