Start-ups, universities and research institutes are able to develop and produce the most innovative ideas. Take for example the University of Ghent and the Catholic University of Leuven in Belgium. At the first clinical phases of their product, these parties often have other things than the large-scale production of their product or process validation on their mind.

However, it’s important for spin-offs to focus not only on research and development, but also on production, process validation and distribution. A product might look promising in the laboratory, but what are the restrictions for large-scale production?

QbD highlights future challenges to spin-offs. We help them to consider and determine how their products need to be developed. Based on our extensive knowledge and experience, we point out all the aspects involved that need to be taken into consideration, from duties and responsibility to process validation and registration dossier. Everything to realise a fast and sound time to market for your new products.