Regulatory Information Management

Iperion can support you regardless of the situation during any stage of your RIM journey

We are system agnostic in the selection of RIM systems and heavily focused on your business needs during the implementation or optimization

Iperion has accumulated experience with all key software vendors in the Regulatory Information Management environment

Our approach to RIM

1. Planning & Setup
   We provide a holistic approach for your RIM solution, fitting your specific business needs, while taking the technical requirements into consideration, such as Master Data Management (MDM) and the use of SPOR.
2. Selection
   Based on our extensive experience, we help you to ensure that the User Requirements reflect your organization’s needs. The fact that we are tool independent, assures you of impartial recommendation.
3. Implementation
   Our holistic approach ensures that key success factors, such as: Data Governance, business processes, business reporting and analytics, take central stage in your RIM implementation.
   In addition, we emphasize the importance of future interoperability and automation of data and processes via systems (e.g. ERP, labeling, DMS, eCTD, etc.).
4. Maintenance
   We can strengthen and stabilize your maintenance operations by providing trained experts. Learn more about our managed services.

Our experts have both hands-on experience with RIM systems, as well as with regulatory activities and procedures.

 

What is RIMS?

RIMS is a system that facilitates and supports business processes for the collection, organization (planning), storage and communication of regulatory information.

Regulatory Information plays an increasingly important role in the life science industry.
It allows for complete portfolio oversight, details of individual products, including changes, as well as interaction with authorities and third parties.

For pharmaceutical companies, RIMS should play a major role in
providing the right information
in the right format
at the right time

This will enable users to make the right decisions.

The role of Regulatory Affairs is changing which is becoming the linchpin of the organization by taking up a role as the information broker, by supplying information to different stakeholders, both within as well as outside the organization.

In the age of digitalization, RIM plays a vital role within life science industry, as a central hub of regulated information, which support many cross-functional processes, such as manufacturing, R&D, clinical trials, pharmacovigilance, quality assurance, etc.

Last but not least, having established a single, reliable source of truth allows for automation of processes (generation of product information, signal detection in pharmacovigilance, providing information for batch release, etc.).

Typical challenges during RIMS implementation

In our accumulated experience, we have identified several challenges with regards to RIMS implementation:

• Short timelines for the selection of the RIMS that fits your needs
• Lack of buy-in from high-management and/or business
• Limited experience with a RIMS, technical requirements and vendor interaction
• No proper setup of User Requirements and/or Use Case for the selection of a RIMS
• Underestimation of importance of defining Data Governance
• Limited internal resources for actual implementation, data collection, migration and training
• Insufficient hands-on experience with selected RIMS
• Data quality issues and magnitude of the legacy data
• Underestimation of the impact of RIM on business processes, including establishing new procedures

WITH OUR EXPERIENCE IN STRATEGIES, REGULATORY OPERATIONS COMBINED WITH THE KNOWLEDGE OF RIM SYSTEMS, WE CAN SUPPORT YOU IN MAKING SURE THAT THE SELECTION AND IMPLEMENTATION OR YOUR RIMS GOES SMOOTHLY.