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Chemistry Manufacturing and Control

Your partner in Chemistry Manufacturing and Control

Chemistry Manufacturing and Control (CMC) encompasses the development, testing, documentation and registration of a new pharmaceutical product, the production process and associated analytical methods. This is a complex process that requires knowledge and expertise in many different areas. Think of the product characterisation studies, stability study, process development, formulation optimisation and the development of test methods. In addition, the product, process and documentation should satisfy the current regulations set by the authorities before the product is allowed to be marketed. The process is time-consuming and can take years. It is therefore important that this proceeds as efficient as possible.

Furthermore, several parties are often involved in a CMC process: the company that developed the product can outsource the production, the analysis and/or clinical studies to other companies. Good and complete transfer of technology from the company possessing the knowledge to the new party is of crucial importance in this process. Hence, a collaboration between several parties in which co-ordination and communication is crucially important.

Progress-PME can offer support in all areas of this process. Our professionals combine years of experience in designing and scaling-up of production processes, developing new (biotechnological) products and project management. They can give you advice during the whole or part of the process. We can co-ordinate the activities, recognise the bottlenecks and can also help your organisation in finding pragmatic solutions. Through the application of Quality by Design and techniques such as Design of Experiments (DOE) and Six Sigma, as well as knowledge of current and coming regulations, Progress helps you to develop Chemistry Manufacturing and Control of the product, thereby preparing you for the future.

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