Drug Delivery
SMC’s experience in manufacturing finished devices from concept to completion is well suited to subcutaneous and intramuscular injection, respiratory and nasal inhalation, transdermal, intraocular, oral, intravenous drug delivery.
Devices are manufactured without the drug or with drug handling under Part 4 compliance for combination products.
Product Development
Early involvement assessments and resulting pilot manufacturing development results in devices for:
- Engineering testing
- Human Factors studies
- Usability testing
- Design Verification testing
- Stability testing
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