We Redefine
CRo Partnerships

About Biofidus

Biofidus AG is a leading (bio)analytical laboratory founded in 2015 by a team of experienced local scientists in Bielefeld, Germany. Responding to the growing demand for outsourced analytics in the pharmaceutical and biotech industries, Biofidus AG provides comprehensive bioanalytical services as a dynamic one-stop partner for new biological entities (NBEs) and biosimilars. Drawing on decades of combined expertise in analytical development and strong connections within the pharmaceutical sector, our founders created a company dedicated to scientific excellence, regulatory compliance, and reliable project delivery.

Since its inception, Biofidus AG has built a strong reputation for high-quality (bio)analytical solutions, driving continuous growth. Today, we are a strong and growing company with a dedicated team of around 35 experts, renowned for our bioanalytical excellence, flexibility, and entrepreneurial spirit.

As a member of the Midas Pharma Group, we are embedded in a global network of 366 specialists across 12 subsidiaries worldwide, expanding our capabilities and international reach to deliver even greater value to our partners.

End-to-end

Seamless Support -From Discovery to Commercialization

Affiliation with Midas Pharma

Being part of the Midas Pharma group gives our customers access to commercial‑stage capabilities, including a broad portfolio of GxP‑related services and regulatory expertise.

In biopharma, this translates into integrated, end‑to‑end support from early development through clinical and commercial stages. Services span the supply of starting materials and intermediates as well as comprehensive combination‑product solutions with an innovative device portfolio.

For clinical and commercial phases, Midas Pharma offers a well-established EU pharmaceutical infrastructure that covers EU import and QP batch release, supporting launch readiness through Marketing Authorization Holder (MAH) services, a full pharmacovigilance system with in-house EU-QPPV oversight, and EU wholesale distribution.

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Contact us to benefit from our reliable and knowledgeable interdisciplinary experience and learn how we define a true CRO partnership.

Why biofidus

We are a family driven company powered by a team of interdisciplinary scientists who redifines what a CRO partnership should look like.

Our holistic analytical platform is designed to address complex structural and functional characterization of  NBEs and biosimilars, delivering precise, decision-ready insights.

From startups to global pharma, and from early R&D through scale-up and commercialization, we provide seamless, end-to-end support, pairing scientific rigor with hands-on work to reduce risk and move projects forward.

Biofidus is a bioanalytical laboratory based in Bielefeld, Germany. We provide analytical and bioanalytical services using spectroscopic, sequencing, cell-based, chromatographic and mass-spectrometric assays. We support projects involving protein biologics, biosimilars, and cell- and gene-therapy products.

We provide (bio)analytical services for the characterization of biologics. With a strong focus on data quality, regulatory expectations, and scientific rigor, we deliver reliable analytical reports, structural and functional characterization, and fit-for-purpose method development. 

From routine high-throughput analyses to the development, qualification/validation, and transfer of client-specific assays, we help you answer complex analytical questions, de-risk development decisions, and accelerate progress from research to clinical development and regulatory submission.

Fast-track your development

We help define, prioritize, and close gaps to streamline and de-risk milestone delivery.

Our Team

Our interdisciplinary Biofidus team accelerates your development with fast, reliable, in-depth characterization of your pharmaceutical product. We help you focus on the questions that matter, delivering the data you need to reach milestones efficiently. We provide one-stop analytical support to solve even the toughest characterization challenges.

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