REGULATORY LABELING AND THE INDUSTRY CHALLENGES
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The document discusses the various challenges organizations face in regulatory labeling, including business continuity, compliance, and technical integration. It emphasizes the importance of understanding these challenges from multiple perspectives—business, functional, and technical. The suggested next step for organizations is to adopt a global labeling excellence framework to navigate these issues.
REGULATORY LABELING AND THE INDUSTRY CHALLENGES
- 1. REGULATORY LABELING AND THE INDUSTRY CHALLENGES A Deep-dive
- 2. 2REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE To comply with time-critical labeling mandates, organizations face many procedural challenges while creating, tracking and managing various aspects of drug labeling lifecycle. In that regard, before even searching for a right labeling solution, isn’t it required to know and decode what exactly are those challenges? Regulatory Labeling and the Industry Challenges
- 3. 3REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE Of, course YES!!! The need of the hour is to understand the challenges from various perspectives, such as: Business-oriented Functional-based Technical / operational Regulatory Labeling and the Industry Challenges
- 4. 4REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE Business Continuity Centralization & Harmonization Fear of non-compliance Impact on brand image Productivity, efficiency and cost Business-oriented Regulatory Labeling Challenges
- 5. 5REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE Establishing processes Pacing with ever-evolving guidelines and region-specific formats Dealing with Knowledge gaps Functional-based Regulatory Labeling Challenges
- 6. 6REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE Technical/Operational Regulatory Labeling Challenges Challenges in CDS creation and deviation tracking Multiple platform Integration Integration of document creation within CDS management Track changes in CDS Document creation, tracking and deviation tracking Deviation reporting and compliance tracking
- 7. 7REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE With the complete spectrum of Regulatory labeling industry challenges defined, what you think should be your next step? Adopt a Global Labeling Xcellence Framework.
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