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.
Pen Injector
A familiar injection pen at an affordable price
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: |
|
| Color: |
|
| Key assumptions: |
|
| Technical documentation: |
|
Convenient size
Excellent patient experience
Step 1
Remove cap
Step 2
Mount needle
Step 3
Dial up and dial down to select dose and prime
Step 4
Insert, inject, remove
We support our customers’ journey
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.
