Putting this into context…
When preparing a dossier gap analysis, we will look at the dossier in relation to the product, and the target country.
This criteria shapes how to look for gaps in the dossier, along with your final objectives. For example, with a generic medicine, the reference medicinal product would need to be suitable for the target country (e.g., the UK). If the reference product wasn’t suitable, biostudies may need to be repeated.
The JensonR+ team would work to highlight any issues like this, summarise and then mitigate the risks offering valuable solutions.