How We Work

As a contracting partner, you will have access to a global network of more than 17 Fresenius Kabi advanced development and manufacturing facilities. Our customized approach and flexibility allow us the opportunity to offer tailored solutions for unique, specialized needs. We strive to increase the support we provide to our partners, and with many years of experience in contract development and manufacturing, we have created a transparent and collaborative way of cooperating with you.

Together, we will determine the best technology and production site based on your requirements. We will then guide you through the setting up of the development and supply partnership. A dedicated team of experts will support you throughout the entire lifecycle of your product, from the early stages of development to the commercial phase.

Our decades of experience in contract manufacturing have resulted in an impressive range of partners, including top-tier pharmaceutical multinationals as well as start-ups and biotech companies. Many of these clients have chosen us as their preferred partner for their entire range of sterile pharmaceuticals and medical devices.

Getting Started

The first step to our collaboration is to establish a confidentiality agreement between Fresenius Kabi and the product-owner. This is followed by the technical consultation and assessment of technical feasibility, after which the parties enter into a contract manufacturing agreement. At this point, there is a technology transfer in both directions, followed by a testing and validation phase. Once this process is complete, contract manufacturing begins.

Get to know our sites, our services and our technologies.

“Best Fit” Evaluation

New products are evaluated in an initial feasibility study in which the best fit between client (location, required services), product (process requirements, product size, markets), and facility (location, on-site technology and support toolbox) is determined.

For each project, we appoint an experienced project team which includes people from all the disciplines relevant to implementing the new processes and products at the manufacturing site. They are able to draw up a fully integrated development and qualification program that includes project planning, risk management, validations, stability studies and regulatory support.

High Quality Standards

At Fresenius Kabi, quality is an integral part of our day-to-day operations, of our business strategy and business philosophy. Our quality management system is designed to ensure compliance with all applicable national and international requirements as well as to meet the expectations of our partners and customers. For us, it is an ongoing task to undertake regular quality improvements across all operations. Our facilities are run in strict compliance with international quality standards (cGMP, WHO-GMP, ISO, ANVISA, etc.).

Focused on Your Success

At Fresenius Kabi, we know how important choosing a reliable contract manufacturer is to your organization. You can count on us for quality, compliance, and collaboration from a team with decades of experience and state-of-the-art production centers in North America, Europe and around the world. We will make you feel like our only client – paying close attention to your needs and marshaling our considerable resources to support you. Let us help you make your next contract manufacturing project a resounding success.