Dossier Gap Analysis

Are you unsure if your dossier is fit for purpose?
Are you planning on purchasing a medicine or acquiring a company that develops medicinal product dossiers?

A dossier gap analysis is a crucial step that should be performed to review the data for a future or 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.

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

Dossier gap analysis

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 an 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 performing 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.

Our experienced team of subject matter experts will advise how risks can be mitigated and offer solutions, as well as highlighting the issues. This allows our clients to understand the real-world implications.

Get in touch with us to find out more