Biofidus AG Information

Biofidus GmbH is a family-owned company powered by an interdisciplinary team of scientists who redefine what a CRO partnership should look like. Biofidus has built a holistic analytical platform for the complex structural and functional characterization of NBEs and biosimilars, delivering precise, decision-ready insights. From startups to global pharmaceutical companies, and from early R&D through scale-up and commercialization, we provide seamless end-to-end support. By combining scientific rigor with a hands-on approach, we help reduce development risks and keep projects moving forward. As part of the Midas Pharma Group, Biofidus gives its customers access to commercial-stage capabilities, including a broad portfolio of GxP-related services and regulatory expertise. Together, Biofidus and Midas Pharma provide integrated end-to-end support for biopharma projects from early development through clinical and commercial stages. The combined offering includes analytical development as well as the supply of starting materials and intermediates and comprehensive combination-product solutions supported by an innovative device portfolio. For clinical and commercial phases, Midas Pharma provides an established EU pharmaceutical infrastructure. Its services include EU import and QP batch release, Marketing Authorization Holder services that support launch readiness, a comprehensive pharmacovigilance system with in-house EU QPPV oversight, and EU wholesale distribution. Imprint: Biofidus GmbH Guetersloher Str. 54 33649 Bielefeld Germany +49 521 329 363 40 www.biofidus.com Management: Dr. Benjamin Müller, Peter Spieth, Jochen Pitzer AG Bielefeld, HRB 46916 USt-ID: DE300823480