White Paper - The Challenge of Regulatory Information Management
Regulatory Information Management (RIM) has been an emerging life sciences industry practice over recent years. At its inception RIM was focused upon adding a degree of intelligence to the management of the global product registration process, by answering questions such as:
- Which products do we have registered and in which markets?
- When is the license renewal for product X due?
- What are the approved product characteristics?
- Where do I need to submit product changes?
- Which health authority responses need preparing and when are they due?
- What actions did I commit to the health authorities?
- Where do we have authorised products that are not marketed?