A/L/P Assembly, Label And Packaging

Pharmaceutical companies developing combination drug delivery systems face increasing pressure to meet regulatory standards while ensuring patient safety and operational efficiency. SMC Ltd. offers a vertically integrated approach to device assembly, labeling, and packaging that supports programs from clinical trial builds through commercial scale. Their expertise spans high-precision molding, automated assembly of delivery systems (including syringes, autoinjectors, pens, inhalers, and wearables), and GMP-compliant labeling and serialization.

With over 35 years of experience, SMC provides scalable solutions ranging from manual to fully automated processes within ISO Class cleanrooms. Their labeling capabilities include precise dosage alignment, tamper-evident options, and global serialization to meet DSCSA and EU FMD requirements. Secondary and tertiary packaging services are tailored for combination products, including temperature-controlled options for biologics and custom configurations for clinical trials.

Compliance is central to their operations, with adherence to FDA 21 CFR Part 210/211, EU MDR, and ISO 13485 standards. A robust Quality Management System ensures full traceability and inspection readiness. Whether preparing for pivotal trials or scaling for global commercialization, SMC’s infrastructure and collaborative approach help pharma companies deliver life-saving therapies faster and safer.