Case Study: Field Blood Typing Card
August 2, 2024
In collaboration with a large OEM, SMC Ltd. developed a prototyped POC cartridge to commercial readiness.
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Assembly, Labeling and Packaging Solutions
Scalable Solutions from Development Through Launch
Trusted Partner for Combination Device Assembly, Labeling and Packaging Services
Enabling Pharma to Deliver Safe, Compliant, and Patient-Friendly Therapies
SMC Ltd. offers vertically integrated solutions for the production of combination devices, supporting programs from clinical trial builds through commercial scale.
Our capabilities span precision molding, drug-device assembly, high-speed automation, and GMP-compliant labeling and packaging. By consolidating these processes under one roof, we help reduce transfer risks and streamline supply chains. More than a contract manufacturer, SMC is a collaborative partner in your product’s life cycle.
OUR EXPERTISE
Comprehensive Assembly, Labeling and Packaging Capabilities
SMC’s integrated approach combines advanced assembly, labeling, and packaging capabilities with deep regulatory expertise and precision manufacturing. From prototyping to fully automated commercial lines, we ensure every combination product meets the highest standards of quality, compliance, and patient usability.
Combination Device Assembly
- Assembly of complex drug delivery systems, including prefilled syringes, autoinjectors, pens, inhalers, and wearables
- High-precision component integration within ISO Class cleanrooms
- Manual, semi-automated, and high-speed fully automated solutions for scalability
- Fully integrated automated assembly lines
Labeling and Serialization
- GMP-compliant printing and application of labels for primary and secondary packaging
- Labeling capabilities down to 0.3 mL syringe wraps
- High-precision placement for dosage alignment
- 100% verification of content and placement accuracy
- Tamper-evident and specialty labeling options
- Global serialization and aggregation capabilities compliant with DSCSA, EU FMD, and other market requirements
Secondary and Tertiary Packaging
- Cartoning, kitting, and packaging tailored for combination products
- Temperature-controlled options for sensitive biologics
- Custom configurations for clinical trial and patient convenience
Compliance and Quality Assurance
- FDA 21 CFR Part 210/211, EU MDR, and ISO 13485 compliant operations
- Robust Quality Management System (QMS) ensuring full material and process traceability
- Proven regulatory inspection readiness (FDA, EMA, MHRA, etc.)
What We Do
Our Packaging and Labeling Services for Pharmaceutical and Medical Devices
High-precision vision inspection systems to ensure packaging quality. Adherence to FDA regulations and current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR). Facilities certified for quality management (ISO 9001) and medical device quality management (ISO 13485).
- Drug and biologics handling
- Chemical and fluid handling
- In-line labeling, bar coding, numbering and serialization
- RFID tagging
- Coordination of sterilization
- Coordination of secondary and tertiary packaging
- FDA-registered, cGMP/QSR compliant, Part 4 compliant
- ISO 9001 and ISO 13485 accredited facilities
- Full product traceability
- Post-sterile product handling through distribution
WORKING WITH US
Your Partner in Patient-Centric Delivery
Whether scaling up for global commercialization or preparing for pivotal trials, we provide the expertise, infrastructure, and reliability you need to bring life-saving therapies to patients faster and safer.
Advanced Pharmaceutical Packaging Techniques
As strategic partners for customers like you, our purpose is to make sure that your innovations are manufactured efficiently, at scale, and that they go to market rapidly, in full compliance with quality and regulatory standards. To make sure that plans are executable and execution goes as planned, we maintain close control over manufacturing with our extensive in-house capabilities. Our best-in-class facilities are ISO 13485, FDA registered, Part 4 compliant, Bio Level 2 certified and cGMP/QSR compliant. As a privately owned, global company, we pride ourselves on the ability to pivot quickly to meet your needs.
Chemical and Fluid Handling
Safe and efficient handling of chemicals and fluids.
Vision Inspection Systems
High-precision vision inspection systems to ensure packaging quality.
Form, Fill, Seal Equipment
Cutting-edge equipment for form, fill, and seal operations.
Tray Sealing and Vacuum Sealing
Tray sealing, pouch coding, opening, and vacuum sealing for secure packaging.
Thought Leadership
Explore Case Studies, Articles and Other Resources
Our contract manufacturing capabilities, focused on single-use and disposable medical devices, include innovative autoinjector platforms designed for subcutaneous or intramuscular injection. These platforms can be customized to your drug formulation.
