Process driven end-to-end Regulatory Information Management

For a mid-sized global client with a wide range of pharmaceutical products and medical devices, mainly IV solutions and clinical nutritionals, Qdossier offers long-term support and RIM program management.

Realizing the global end-to-end RIM strategy

Qdossier takes the lead in defining and realizing the global end-to-end RIM strategy to address the current challenges in Regulatory Information Management. This includes replacing the current RIM system, which offers the following capabilities:

  • Regulatory product master data
  • Registration planning and tracking
  • Submission forecasting
  • Committment and interaction management
  • XEVMPD submission management
  • Reporting and analytics
 These capabilities are to be integrated with the existing document management system, ERP system and submission management platform. Furthermore an integration with the system used for managing Falsified Medicines Directive (FMD) submissions must be realized. The new system will also follow IDMP requirements.

Aligning complex and deviating processes across divisions

The global system handles 4000+ authorized products. Data is managed in a centralized model by four different divisions, with multiple global and regional hubs. This has resulted in various complex and deviating processes which have to be further harmonized, aligned and detailed.

The current system is operated in a data oriented manner and difficult to use consistently across contributors. Access is limited to a group of key users only, which has resulted in a disconnect between daily business and records management. This gap must be closed by moving to a intuitive and process oriented operating model.

Strategic and operational activities

The various cross-functional IDMP awareness sessions hosted by Qdossier have led to the identification and involvement of all stakeholders and helped launching the global program. Our experts helped the client defining a new RIM strategy, setup a program team and steering committee and define and prioritize the projects which are part of the program.

Qdossier helps with the vendor selection, user requirement specficition, pilot phase and modelling of the target business processes. Subsequently our experts will be involved in data migration, testing, validation and training.

In parallel our data management group continues to deliver outsourcing services to support daily business operations, incl. registration tracking, reporting and XEVMPD submissions. 

Customer benefits

The long-term in both strategic and operational activities brings a lot of value for the client; our collegues in the data management group know (and are part of) daily business and experience the operational challenges direclty. Our consulting experts are in daily contact with them and immediately anticipate on the challenges found when redefining related business processes and designing the workflows in the new tool.