Digital transformation of multi-jurisdictional compliance for a pharmaceutical multinational

A pharmaceutical multinational, operating throughout Europe, turned to us to optimize document management for Regulatory Affairs and ensure compliance with the guidelines of global regulatory agencies, such as the EMA.

Training on partial or insufficient datasets can significantly compromise the accuracy and reliability of a Machine Learning model; while a varied and precise dataset ensures that biases are minimized and result accuracy is high.

Operational difficulties concerned the many directive documents that were fragmented due to the various management systems. Operators spent up to half an hour searching for simple information among dossiers and identifying the most up-to-date version. All this had a clear impact on productivity and internal deadlines.

Moreover, conflicts between different global guidelines made timely adjustments to drug regulations difficult, causing both risks of non-compliance and the need for frequent manual process reviews. For company management, it became a priority to introduce a unified system capable of reducing search times, ensuring complete traceability, and simplifying alignment with international requirements.

To address these challenges, we integrated AVAPharma into the client's existing management system, creating a structure integrated with the main systems used in the company, such as Veeva Vault for regulatory document management, the clinical trial management system, and other industry databases. The goal was to create a single connected and intelligent ecosystem, capable of drastically reducing fragmentation and increasing team efficiency.

Key features introduced include the management and classification of regulatory documents. Thanks to industry verticalization and advanced semantic search, operators can query the entire document corpus in seconds, with the ability to leverage auto-classification by type and automatic extraction of key information from Clinical Study Reports. In addition, an intelligent version control system tracks critical changes and ensures work is always done on the latest available version.

Another pillar of the work was the multi-jurisdictional compliance support module. Thanks to targeted Web Search, the client was able to consult, in a single tool and in real time, new guidelines issued by FDA, EMA, Health Canada, PMDA, or similar, performing automatic cross-referencing between the various recommendations and highlighting any conflicts.

Through intelligent alerts, operators are now immediately notified when a regulatory update impacts an ongoing submission, while the automatic creation of predictive dashboards enables the extraction of approval timelines based on the latest trends. Furthermore, thanks to AVA Pharma, it is possible to automatically generate templates compliant with the latest guidelines of each authority, significantly reducing the risk of errors and duplications.

In this way, the company has transformed a slow and fragmented process into an integrated workflow, capable of ensuring speed, traceability, and full compliance with global regulations.