Optimize your product development with our Quality by Design (QbD) approach. We help you to understand processes better and develop products faster.

Together we define quality attributes, set the design space, and establish a precise control strategy. Increase the efficiency of your processes and improve the quality of your products with our innovative solutions.

We believe in the Analytical Quality by Design (AQbD) approach to design methods that meet the highest quality standards while offering regulatory flexibility.

By applying AQbD we enable the adjustment of method parameters within the developed ranges, also known as Method Operable Design Region (MODR), during the entire life cycle of the method. This innovative approach not only allows flexibility, but also contributes to the reduction of deviations, such as out-of-specification (OOS) or out-of-trend (OOT) results.

Our expertise in the field of AQbD covers scientific feasibility studies as well as the development of quality control methods. Thereby we support our customers in all phases of product development and allow them to bring high-quality products to the market quickly and efficiently.

When developing a method or process, the “One Factor at a Time” (OFAT) approach is usually followed by varying one factor and keeping the others constant in order to investigate the effects. In contrast, the “Design of Experiments” (DoE) method allows for the simultaneous variation of all factors in a single set of experiments. DoE provides information about main effects and interaction effects of several factors on the results. Through many scientific publications it has been demonstrated that DoE is superior to OFAT. It enables an efficient search for solutions with a smaller number of experiments and a greater learning effect without losing quality.

We use DOE as a tool for the successful implementation of “Quality by Design” (QbD). Whether for the development of a new product or the variation of an analytical method – we support you by applying DoE.