Combined ATMP - Support at the front line of progress - anteris medical contributes to the development of a Combined ATMP
Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury. anteris medical is proud to contribute to the development of a Combined ATMP comprising of human tissue cells (medicinal product) and a biopolymer (medical device) intended to be bio-printed as 3D organ. Our support in the project covers the complex coordination with a multidisciplinary project team with responsibility for requirements engineering, risk management, human factors studies, quality plans, release procedures and design verification planning and reporting etc., as well as managing the challenging regulatory requirements for the medical device part.
The combined ATMP is a challenging and exciting project, perfectly fitting our claim to significantly contribute to product development.
- Combination product
- Design Control
- Quality system
- Supplier management
- Bringing together pharma and device language
- Streamline procedures and address the specific device requirements of combined ATMP development
- With anteris medical´s experience in combination products, understanding of „both worlds” – pharma and medical devices – we are able to efficiently implement device requirements in a groundbreaking product development
- Deep understanding of combination product requirements of FDA and EMA