A familiar injection pen at an affordable price

The Pen Injector is an important addition to Phillips-Medisize’s expanding Product and Platform portfolio, empowering Biopharmaceutical 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 FeaturesDetails
The customer can customize the pen to meet requirements for therapies including:
  • Growth hormones
  • Diabetes
  • Fertility
  • Osteoporosis
Customer specified dose size:
  • Variable dose
  • Pre-set doses (‘fixed dose’)
  • Units: mg, ml, or IU
Color:
  • Cartridge holder and push button color customizable
Key assumptions:
  • Pen design allows stopper lengths between 8mm and 11mm
  • Cartridge volume 3ml or 1.5ml
Technical documentation:
  • Technical files support the customers' submission to FDA and EMA
  • Technical files to support submission to cover other markets on request

Convenient size

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.

Get started with the Phillips-Medisize pen injector platform

Bringing Possibilities to Life

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