anteris medical’s expertise contributed to the successful development of an autoinjector combination product
For a global pharma company anteris played a vital role in the end to end development and approval of a potential blockbuster biologic pharmaceutical. In the role as project leader anteris had the responsibility for the progress of the complete autoinjector development including supplier management. Furthermore, anteris consultants took responsibility for several technical development roles including Requirements Engineering, Risk Management, quality plans, release procedures and design verification planning and reporting. During commercialization anteris medical contributed to the design transfer to an external manufacturing site, which required to connect the device aspects of two different gmp systems.
We were proud to contribute to the combination product / device parts of the regulatory dossiers which were handed in at FDA /EMA and were finally approved.
- Combination product
- Multiple quality systems
- Supplier management
- Design Control
- Bringing together pharma and device language
- Implement device aspects into a gmp organization with low experience with device development
- With anteris medical´s understanding of „both worlds” – pharma and medical devices – we are able to efficiently implement device programs in an gmp organization
- Deep understanding of combination product requirements of FDA and EMA