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 final 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.
SHL Medical offers technical support to ensure correct design transfer for customers who perform final assembly of an SHL Medical-designed device at their own site*. Specifically, customers are supported during the planning phase, including control strategy definition, equipment URS development, and qualification and validation strategy planning. SHL Medical further provides support during the execution phase, including risk assessment, qualification, and validation of pre-requisites, and continued monitoring.
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. Our studies are conducted in facilities that comply with FDA regulations and ISO standards and support the manufacture of CE-marked products. All 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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Partnerships
We are building a partnership network in various areas to enhance offerings for customers along the entire device value chain.