The Pen Injector is an important addition to Phillips-Medisize’s expanding Product and Platform portfolio, empowering Biopharma companies to accelerate the rollout of novel and generic drug treatments at significant economies of scale.
A disposable pen for multiple therapies
This ‘ready-to-go’ solution offers all of the advantages expected from ‘state of the art’ pen designs, while benefiting from our decades of device development and large-volume manufacturing expertise to reduce the challenges of bringing affordable drugs and drug-delivery devices to market.
Sample devices currently are available to support technical evaluation and human factors studies, with clinical devices scheduled to be available by the end of 2023.
|Pen Injector Features||Details|
|The customer can customize the pen to meet requirements for therapies including:|
|Customer specified dose size:|
Excellent patient experience
Dial up and dial down to select dose and prime
Insert, inject, remove
For the U.S. Food & Drug Administration (FDA) and European Medicine Agency (EMA) submissions we deliver:
- Technical specifications for pen components are provided to support customers in development of pen and cartridge assembly lines
- Part build services available for stability studies
- Technical files are prepared that customers can reference in their drug approval applications with the FDA and EMA
- Technical files for customer-specific pen customizations can also be provided
- Our customers remain the marketing authorization holder for their drug-device combinations
Technical files can be prepared for other regions and regulatory bodies.