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Our Approach

Our ApproachDoing contract manufacturing of sterile medical devices requires careful planning and allocation of resources in order to safeguard excellent performance at all stages of the partnership. At the same time, it requires flexibility throughout the organization so that services can be customized to the needs of each partner. Key features of our approach are our "Best Fit" evaluation, and our project management and risk management programs. We value open and direct communication between your and our staff at every stage of the partnership. This key skills qualify us to be the right partner for producing your sterile medical devices.
 

"Best Fit" Evaluation

Our Approach - Best Fit EvaluationOne of the first steps we apply in designing an offer to our partners is a "Best Fit" evaluation. In this model, client requirements, product characteristics, and manufacturing site competencies are evaluated together in order to arrive at a development and/or manufacturing strategy that provides the highest added value for our partner in the short term and long term. This means that we offer concepts that we can commit ourselves to supporting during all stages of the cooperation.
 

Project Management

Our Approach - Project ManagementFor each new project, we appoint a project team who have the job of securing the progress of the project. The team 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 validations, stability studies, regulatory support and all other elements relevant to a specific product. Of course, you our partner are closely involved in the creation of this project plan. Again, open and direct communication is of the essence in minimizing time to market.