Many important advances in clinical practice, such as biomarker-oriented research or advanced therapeutic medicinal products originate from academia. However, translating research findings into medicinal products for clinical practice requires knowledge and skills that usually do not reside in public research institutes. For example, to advance the innovative medicinal product further to clinical practice, the product needs to comply with quality and manufacturing standards and a dossier needs to be compiled that meets the requirements for regulatory acceptance.
It is important not to miss the right time to start focusing on the translation of the product to clinical practice. Even at an early stage it is possible to discuss the development of a product with health authorities and ask guidance (scientific advice). This will enable you to anticipate on the expectations from health authorities and will help focusing on regulatory issues relevant to further develop the product. It might result in a slight shift in research focus, but on the other hand it might make the project more appealing for funding as well.
At StaroDub BV we can support the preparation of the scientific advice meetings with health authorities. In addition, with us you also benefit from additional SME incentives in the EU. Would you like to know more, or are you considering to request for a scientific advice? Don’t hesitate to contact us with any questions!
