Combining Human Needs With High Viscosity Formulations
February 14, 2025
Within the injectable drug landscape, the availability and usage of high viscosity (HV) drugs is growing, often driven by developments…
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CDMO Pharma Services and Solutions
Comprehensive Support at Every Stage
Trusted CDMO Services for High-Stakes Pharmaceutical Programs
When pharma partners around the world need to deliver complex, compliant and complete drug delivery systems with unrivaled speed, agility and care, they turn to SMC.
Supported by state-of-the-art facilities and populated with cutting-edge equipment, our expert team has the experience, capability and resources required to support your drug product, from bench to market and onto lifecycle management.
We share your vision. We work as hard as you do. We care as much as you do. We match your energy and combine our empathy to deliver.
WHAT WE DO
Complete Pharmaceutical Commercialization Services and Capabilities
At SMC, we partner with you through every stage of your pharmaceutical product’s journey. From early formulation development to maximizing ROI on your market-ready product. Our dedicated team focuses on delivering flexible, efficient, and cost-effective solutions tailored to your needs. With a full spectrum of in-house capabilities, we provide a seamless, end-to-end service that ensures your product’s success.
Our state-of-the-art, purpose-built facilities are compliant with cGMP, FDA, EU, and MHRA standards, supporting the full range of your pharmaceutical development needs.
Specialized Services for Pharmaceutical Device Development:
Early-Stage Development and Manufacturing
- Formulation development, API mixing, bulking, and scale-up
- Prototyping, proof of concept, and process development
- Design for manufacturability and assembly
- Clinical manufacturing services
- Fill-finish process and equipment development
- Comprehensive program management with custom tooling and automation solutions
Sterile Filling
- Aseptic processing and terminal sterilization coordination/support
- Small-batch manufacturing for clinical trials
- Cartridges, syringes, vials, and custom container solutions
- State-of-the-art cGMP-compliant facilities
Assembly, Labeling, and Packaging Solutions
- Post-fill device assembly
- Product kitting and labeling services
- High‑precision labeling and serialization capabilities, including tamper‑evident labels and global aggregation support
- Secondary and tertiary packaging solutions tailored for clinical and commercial products
- Temperature‑controlled packaging options for sensitive products
Supply Chain Management
- Global supply chain management and facilities support
- In-house global supply team
- Robust resource planning and scheduling systems
- Continuous monitoring and evaluation of supplier performance
- End-to-end distribution support
Quality Control and Compliance
- Regulatory submission support for devices and pharmaceuticals
- Advanced quality planning and risk management
- ISO 13485 certification
- Compliance with FDA 21 CFR Part 4 requirements
- Meets meet cGMP, FDA, EU and MHRA standards
Analytical Services
- Analytical testing and container closure integrity (CCI) assessments
- Environmental monitoring and clean room analytics
- Bioburden and sterility testing support
- Microbiological identification and endotoxin analysis
WHO WE ARE
Discover Our Holistic, Problem-Solving Approach to CDMO Pharma Solutions World-Wide
SMC has spent more than three decades enabling pharmaceutical, medtech, and diagnostic innovators to reach their goals faster and with greater confidence. By aligning seasoned experts with every phase of development and manufacturing, we offer a uniquely seamless and comprehensive service portfolio that supports your product from concept to commercialization and beyond.
FaqS
Frequently Asked Questions about SMC and Our Pharma Services
What are the differences between each manufacturing facility?
All SMC facilities are designed to produce high-volume medical devices, but each location has unique specialties. For example: SMC Somerset specializes in silicone manufacturing. North Carolina serves as our dedicated fill-finish location. Our facilities are strategically located to provide convenient access and support to our customers. To determine which facility is best suited for your project, we recommend reaching out to us for personalized guidance.
What makes SMC different from other CDMOs?
At SMC, we stand out among other CDMOs (Contract Development and Manufacturing Organizations) because of our unique approach and capabilities. Not only are we a privately held company with an actively engaged management team, but we also specialize exclusively in medical manufacturing, serving the medical device, diagnostic, and pharmaceutical markets.
Our end-to-end manufacturing solutions cover everything from design to production, including fill-finish capabilities. With subject matter experts (SMEs) available every step of the way, we ensure a seamless process tailored to your needs.
What truly sets SMC apart is our proprietary auto-injector technologies, which we offer exclusively to our customers.
When does SMC prefer to get involved with a new project?
At SMC, the sooner we can get involved, the better! However, we’re happy to assist at any stage of your project. Whether you’re starting with a simple concept—like a napkin sketch—or transferring a fully developed program through a lift-and-shift process, we’re here to help.
It’s always best to engage your Contract Manufacturer (CM) as early as possible during your program’s planning phase. Early collaboration allows us to partner with you effectively and thoroughly review the manufacturing aspects of your project for optimal success.
Do you have a purchasing organization that manages the supply chain?
At SMC, the collaborative supply chain teams, led by our Chief Supply Chain Officer, employ best-in-class techniques to ensure customer success on a global scale. The SMC-approved supplier list includes multiple alternatives for all major commodities, providing diverse sourcing options to mitigate risk. We collaborate closely with internal stakeholders, including finance, engineering, operations, and legal teams, to ensure alignment and support for procurement strategies tailored to address customer concerns and needs. By building and nurturing strong relationships with key suppliers and partners, we leverage strategic advantages that foster innovation, enhance pricing power, and provide flexibility in production and transportation.
Key performance indicators (KPIs) are utilized to measure the effectiveness of procurement strategies and operations, driving continuous improvement in supply base processes, systems, and practices. Our approach anticipates and mitigates risks by accounting for economic, geopolitical, and environmental events that may impact procurement and supply chain operations. Additionally, we achieve buying power through a combination of concentrated spending with key suppliers, independent pricing and minimum order quantity (MOQ) negotiations, and the use of purchasing data and forecast extrapolations.
How do you manage risk for your customers?
Our success in managing potential supply risk is rooted in our focused approach across several key areas. We maintain a strong core of senior technical and commercial leaders within SMC, ensuring that experienced leadership drives risk management efforts. Identifying supply risk areas and implementing mitigation strategies is a core responsibility of our senior management and their teams. To stay ahead of our customers’ capacity needs, we pre-invest in infrastructure, ensuring preparedness and adaptability. Consistent technology investments enable us to mitigate risks related to both obsolescence and security.
Additionally, we provide safety stock of both raw materials and finished goods to support our customers’ needs. Where applicable, we employ dual sourcing for critical components to enhance supply chain resilience. Lastly, site-specific business continuity plans allow us to respond quickly and effectively to unexpected events, minimizing potential disruptions
Are you ISO Certified?
Yes, all SMC Facilities are ISO 13485 Certified and FDA registered.
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.
