Dossier Gap Analysis

A dossier gap analysis is a crucial step that should be performed to review new data for a future marketing authorisation, or before the acquisition of an existing marketing authorisation. It serves, as a core part of your company’s due diligence process. Ensuring the completeness and compliance of the product data set with the latest regulations is vital before any significant submission or acquisition.

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)

Dossier gap analysis

Further insight into the individual modules contained within the medicinal product dossier can be found on our Dossier Module Writing page.

To maintain a marketing authorisation, or when applying for a new one, each module must be compliant with industry standards and current local regulations. Performing a dossier gap analysis offers reassurance that all necessary data is present before proceeding with a marketing authorisation application or acquisition.

During the dossier gap analysis, we thoroughly review each module to ensure compliance with the latest regulations and industry standards. If any gaps are identified, our experts will work to address them, thereby increasing the likelihood of a successful validation and reducing the number of Requests for Information (RFIs) from the health authority. This leads to a faster market access and earlier product launch.

Once any issues within the dossier have been identified and rectified, our team can also handle the dossier publishing and submission on your behalf.

In addition to dossier support, JensonR+ is well-equipped to support you in other areas of your company’s due diligence processes. For more information, please refer to our Due Diligence page.

When preparing a dossier gap analysis, JensonR+ regulatory experts will look at it in relation to the product and the target country. As members of the regulanet® network, we can consult and collaborate with international partners, giving us valuable insight across the regulatory landscape. This criteria shapes how to identify gaps and achieve your final objectives. For example, the reference medicinal product for a generic medicine must be suitable for the target country (e.g. UK). If the reference product is not suitable, biostudies may need to be repeated. We will highlight issues like these, summarise, and then mitigate the risks, offering valuable solutions.

Get in touch with us to find out more