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.

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

Oval Medical Technologies provides autoinjectors to meet the needs of patients and a broad range of drugs including biologics. As an SMC Ltd. Company, we provide customers with complete service from customization of subcutaneous and intramuscular platforms, to production of clinical trials devices and commercial scale manufacturing.

A customized autoinjector, with customized primary drug container, allows complete control over critical component tolerances and control over manufacturing schedule needs. More…

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