Today’s life sciences industry faces many challenges. Drug development costs continue to climb, there is a lot of pressure on pricing, and new global markets gain critical importance.
Besides that, the FDA, EMA, and other regulatory bodies are expanding and revising requirements, clinical trials are becoming more complex, and information systems and information technology are changing rapidly.
Therefore new Regulatory Information Management (RIM) approaches and technologies for better management of and access to regulatory information are required. Regulatory data and the related information are important corporate assets, supporting many cross-functional processes such as manufacturing, R&D document authoring and clinical trial submissions. Too often information management strategies and systems are not designed to cross organizational boundaries. Regulatory document creation and information management in a life sciences company cannot be seen as separate activities.
Indeed, such data is used by many departments within the company for such activities as business development, marketing, labeling, supply release, local affiliate tracking, and for third party information exchange and collaboration. It is very frustrating for companies not to have a holistic view of regulatory information management as an enterprise-wide process.
Large global enterprises can benefit from RIM systems that integrates comprehensive global regulatory information into a single regulatory information management system.
- IDMP ready!
- Application procedure management
- MA portfolio management and licensing tracking
- Logistic – Regulatory Affairs synchronized business processes
- Alignment of central and or local organized regulatory affairs departments
- Business decision support – regulatory compliance
- Extensive standards complaint
- Labeling and packaging changes