We provide complete assembly, labeling, and packaging services for drug delivery devices. With facilities in the US (Florida) and an alliance partner in Europe, we offer seamless solutions that ensure the highest quality standards.
Our state-of-the-art facility in Deerfield Beach, Florida, is a leader in final assembly services, offering equipment qualification, process development, design transfer, and turnkey assembly. Equipped with advanced labeling, packaging, and serialization capabilities, we deliver end-to-end solutions tailored to your combination product needs, ensuring precision and efficiency at every stage.
Customers benefit from SHL Medical's expert technical team and extensive experience, leveraging a wealth of knowledge in developing, troubleshooting, qualifying, and validating final assembly processes. With expertise across various equipment types—Manual Assembly Machines (MAM), Semi-Automated Assembly Machines (SAAM), and Fully Automated Assembly Machines (FAAM)—we support a wide range of autoinjectors, from platform to bespoke devices, utilizing syringes or cartridges. This comprehensive approach ensures optimized processes and exceptional outcomes.
With extensive expertise in assembly, labeling, packaging, and regulatory compliance, we offer comprehensive solutions to streamline production processes, enhance efficiency, and optimize timelines. Our services are tailored to support clients in achieving their clinical and commercial goals, ensuring high-quality outcomes and seamless delivery throughout every stage of development and distribution.
We offer technical support to help customers set up the final assembly of our devices at their own sites (If customer is not using SHL Medical Final Assembly and Packaing for final assembly). Our support begins in the planning phase, covering control strategy, equipment requirements, and validation planning. During execution, we assist with risk assessment, qualification, and continued monitoring to ensure a smooth design transfer process and maintain high standards throughout.
We offer expert design support for device label and carton packaging specifications, optimizing design, size, placement, and equipment compatibility to reduce change parts or new equipment needs, saving time and cost. Our service includes reviews of additional features like NFC and light protection, and covers labeling, packaging, or both. Prototyping and trial runs help minimize risks during qualification and validation.
As an SHL Medical customer, you can count on our regulatory support for additional market launches. We help develop effective regulatory strategies for delivery devices, preventing costly delays and mistakes. Our support extends through all stages of product development and throughout the entire product life cycle.
We provide stability studies for combination products to support global regulatory filings. Conducted in FDA, ISO, and CE-certified facilities, our studies follow ICH Q1A(R2) and ICH Q1E guidelines. We also perform subassembly aging studies per ASTM F1980 and ASTM 3045. Available for autoinjectors, our services save time by accommodating various configurations and direct storage at our facility in Deerfield Beach.
Covering the full drug delivery value chain, we provide peace of mind by offering end-to-end services.
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Products
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Partnerships
We are building a partnership network in various areas to enhance offerings for customers along the entire device value chain.