(EU) 2023/607, 26th May 2024 deadline approaching

The Future of Health Grant welcomes confinis as a new Program Partner

Transitioning to the Medical Device Regulation (MDR) 2017/745


The project management Quality support provided by confinis was exceptional. The project included implementation and launch of a major biologic PFS for the US market with an aggressive timeline. Not only did we meet the project timeline, but we filed one month early. The support provided by confinis was instrumental in meeting and exceeding our goals. Well done!

Director, Global Biotech Company

Peschke appreciates the specialized expertise for regulatory challenges in the area of combination products. For us this missing piece is key to success to access the important US market. The professionality and expertise of confinis is overwhelming, and we can highly recommend them whenever FDA related topics occur – Great people behind a great business!

Yvette Viscuso, Managing Director Peschke Trade

confinis not only supplies expertise for regulatory challenges in combination products, but operates as a member of our team, driving and guiding complex regulatory processes and helping us to understand the requirements while building up our knowledge.

Senior Manager, Global Biosimilar Company