Dossier Compliance:
Gap Analysis to Guarantee Successful Submission.
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Summary.
Our client, an EU-based generic pharmaceutical company, was looking to expand their portfolio of small molecule products for a defined group of EU member states.
The client sought support with performing several regulatory gap analyses for the dossiers that would be considered for licensing.
Our expert team was requested to:
- Coordinate gap analysis and dossier availability with the different dossier licensors.
- Perform a complete gap analysis of the dossier.
- Highlight what information and/or updates would be needed for the dossiers for an EU submission.
- Deliver a final opinion on the quality of the dossier.
Challenges.
The main challenge, from the client’s perspective, was the lack of internal expertise to perform the full dossier gap analysis, from CMC to non-clinical/clinical. In parallel, the client’s strategy focused on the portfolio expansion for a certain group of member states with the EU – and not all products would be intended for the same member states.
Therefore, the gap analysis of each individual dossier had to focus not only on the product itself and its characteristics (drug substance, pharmaceutical form, strengths, etc.), the EU requirements and guidelines, but also on each individual Agency and on their assessment and RFIs issued.
In this sense, the client recognized Arriello’s experience in regulatory gap analyses, especially across different types of products, pharmaceutical forms and markets. Even though EU guidelines are broadly aligned and followed through, Arriello’s team knows how each EU-state tends to focus on different areas or key topics, and the team’s experience allowed for anticipation of those different questions and how to address them.
Arriello’s background in this type of work was a key reason why the client reached out.
Solution.
We assembled a dedicated global regulatory team with broad experience of dossier writing and EU regulatory submissions, providing the client with a single point of contact to ensure efficient communication and coordination.
The team aligned with the client to guarantee the colleagues involved in the project had access to the dossier, provided by the licensor, to perform the assessment of all modules.
The Arriello team performed a gap analysis of the full dossier, from module 1 to module 5.
Based on this assessment, a final report was prepared, where the team included:
- Comments and findings for each section and sub-section, with recommendations on the updates that should be made or on information that Agencies would be expecting to see. These were based on technical requirements, EU guidelines and legislation (always referenced, as applicable), and from the team’s experience with previous interactions with those specific member states.
- A conclusion for each section/sub-section, if it was compliant with the requirements and the expectations from the specific member states.
- Information that was found in the dossier and considered important (even if correct and aligned with legislation) was also added, for the client’s knowledge.
Our Holistic Approach.
Arriello took a structured approach, blending deep regulatory expertise with strategic insight for each specific dossier/product. A dedicated project manager acted as a single point of contact, ensuring seamless communication and efficient management of all interactions with the client.
As a result, the client was able to make informed decisions (go/no-go) on the licensing of these specific dossiers, based on the quality of the information shared, and on the risk it would mean for an EU-submission to the identified member states.
Need support with EU dossier gap analysis? Contact Arriello to strengthen your submission strategy.
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