Drug Delivery Contract Manufacturing

A trusted, experienced manufacturer of drug delivery devices

SMC’s experience in manufacturing finished devices from concept to completion includes devices manufactured without the drug or with drug handling under FDA CFR 21 Part 4 compliance for combination products. This includes handling of drugs and biologics in primary packaging for integration into the final device assembly.

SMC is a global manufacturer dedicated exclusively to custom contract manufacturing for the healthcare market. All manufacturing facilities are FDA registered and ISO 13485 certified and select facilities are licensed for drug handling with .

We have worked with leading pharmaceutical companies on a wide range of drug delivery solutions for which our capabilities are well suited, including:

  • Subcutaneous injection devices
  • Intramuscular injection device
  • Transdermal drug delivery devices
  • Intravenous drug delivery devices

Strategic Capabilities and Services for Device Manufacturing

With a knowledgeable staff that includes in-house engineering, automation and assembly expertise, SMC is a leading resource for drug delivery device manufacturing. Our best-in-class facilities around the world provide:

Design and development

through all stages of the product life cycle

Program Management

including the handling of drugs and biologics in their primary packaging such as aluminum canisters, capsules, glass or plastic cartridges and syringes, or in pill form

Injection molding

including in-house tooling and expertise in silicone, thermoplastics and micro/mini components

In-house automation and assembly

including ISO Class 7 and 8 clean rooms

Quality and regulatory capabilities

including extra security and infrastructure for controlled substances

Expert Oversight for Complex Pharmaceutical Processes

Devices that utilize a drug or other formulation may demand isolation of some processes, as well as special storage. SMC will address those requirements and establish the needed protocols to ensure your finished device is fully validated and compliant.

At the same time, our rigorous program management process and in-house automation capabilities and expertise enhance the efficiency of the manufacturing process.

Product Development

Capabilities include early involvement assessments and pilot manufacturing development for devices used in:

  • Turn-key device design & development
  • Device design verification
  • Feasibility assessment
  • Human factors studies
  • Performance testing
  • Prototypes, small builds

Clinical Manufacturing

Clinical trial devices are manufactured using process validation (IQ/OQ/PQ), with regulatory documentation support providing finalization of:

  • Product specifications
  • Functional testing
  • Design freeze
  • Packaging and labeling

Commercial Manufacturing

With FDA pre-approval inspection, product life cycle is managed with scalable manufacturing:

  • Launch with pilot solution
  • Increase capacity to forecast
  • Implement semi-auto solution
  • Implement fully auto solution

Streamlined efficiency for drug delivery device manufacturing

In-house automation and supply chain expertise set SMC apart. 

We can design and build automation stations to complete critical assembly tasks and perform rigorous quality checks. For high-volume device solutions, our in-house automation experts work closely with established suppliers of high-speed automation systems. 

Our engineers and supply chain experts continuously monitor supplier metrics to ensure the supply chain is efficient, competitive, on time, and delivers high quality and value.

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