Due Diligence and Gap Analysis (Quality Compliance)

In order to maintain the validity of a marketing authorisation (MA) of a medicinal product, an authorised dossier requires to be continuously updated.

The examination of data and documentation included in the dossier is a very important aspect in the case of acquisition of pharmaceutical dossiers, or when a MA application is going to be submitted in Italy or in other countries.

Actually, it often happens that the documentation in the dossier does not comply with the latest regulatory standards, with all concerned quality aspects of a drug, or even presents relevant gaps.

Therefore any potential gap as well as their impact on the registration procedure should be identified in time, by defining all necessary regulatory actions to be taken.

Thanks to the presence of several regulatory experts among its staff, Di Renzo Regulatory Affairs can assist companies carrying out Due Diligence and Gap Analysis of registration dossiers, to examine the state of the documents and providing strategic assistance to business decisions.

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