anteris medical contributes to the development of an On-body Injector and helps its customers to select a suitable partner
On-body injectors are not new on the market, there are many types, especially for insulin. But since Amgen received approval for Neulasta® Onpro®, the market has changed. Companies that already have a PFS or an autoinjector on the market, as well as complete newcomers, are now focusing intensively on this topic.
We support our customers in all questions related to the Medical Device part. Starting with the selection of a suitable partner, through the preparation of a threshold analysis, release procedures and design verification planning and reporting etc. to discussion and submission to the EMA and/or FDA.
Our support in the project covers also the complex coordination with a multidisciplinary project team with responsibility for requirements engineering, risk management and human factors studies.
- On-body Injector
- Combination Product
- Threshold Analysis
- Human Factors studies
- Verification testing
- Selecting a suitable partner
- Bringing together pharma and device language
- Deep understanding of Combination Product requirements of FDA and EMA
- Coordination with a multidisciplinary project team
- Support with verification testing and Human Factors studies
- Support of the regulatory dossier