confinis - regulatory compliance worldwide

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.

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!

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!

We are very happy with our choice of confinis as a one stop shop QA/RA partner to Neo Medical, supporting our growth from a start-up to an international company. confinis has provided expertise in everything from quality management, design control, clinical evaluation, internal and supplier audits, CE marking, 510(k)s to global registrations. I highly recommend confinis!