Dossier gap analysis
Before any important submission or acquisition, it is critical that the product data set is complete and compliant with the latest regulations. A dossier gap analysis can be performed as a review of new data for a future Marketing Authorisation, or before acquiring of an existing Marketing Authorisation.
The medicinal product dossier is comprised of 5 modules:
Module 1 – Administrative information and prescribing information
Module 2 – Overviews and summaries of Modules 3–5
Module 3 – Quality (pharmaceutical documentation)
Module 4 – Non-clinical reports (pharmacology/toxicology)
Module 5 – Clinical study reports (clinical trials)
To maintain a Marketing Authorisation, or apply for a new one, each of these modules must be compliant with industry standards and local regulations.
With a dosser gap analysis, we will review if these modules are completed to current regulations and standards. If any gaps are identified, they can be mitigated, ensuring a successful validation, reduced number of RFIs (questions from the Health Authority) and faster market access.
Our team can also publish the dossier and perform the submission, see our eCTD publishing and Regulatory Submissions pages for more information.
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.