Best Fit Evaluation
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 them.
The first step to start the collaboration is to establish a confidentiality agreement between Fresenius Kabi Contract Manufacturing 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.
Doing contract manufacturing requires careful planning and allocation of resources, in order to safeguard excellent performance at all stages of the partnership. Key features of our approach are our "Best Fit" evaluation, as well as our project management and risk management programs. To achieve a cooperative strategy that provides the highest added value for our partner, Fresenius Kabi Contract Manufacturing will choose the right manufacturing site based on the project's requirements and guide the process of setting up of a development and supply partnership. 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.