Are you looking to apply for an operating licence and do you need a pharmaceutical quality management system to achieve this?

Has your quality management system grown to such a point that it is becoming too hard to manage?

Your needs are our bottom line, and we focus on how we can provide maximum benefit to your company.

The objective of quality management lies not only in organising and monitoring GxP processes, but also in balanced and stable process control, and in resolving process gaps as part of an actively pursued Continuous Improvement Process.

Aided by efficient tools, reliable and standardised end-to-end processes are designed to be effective and to move your business forward, while enabling all parties involved to retain a good overview of key information.

To enable targeted implementation of these processes, we need to know the impact level and its effects so that the necessary levers are used to best effect.

In developing or optimising quality management systems, we take a risk-based approach to creating a suitable operating model.

Our focus is on integrating the knowledge holders in your company and enabling them through the use of information and training.

Service elements

• Evaluation of the operating licence required for a specific activity
• Development of a QMS to obtain an operating licence
• Optimisation of an existing QMS
• Standardisation of individual processes
• Implementation of global requirements at local level