Indegene Labeling and Artwork Solutions
Transcript of Indegene Labeling and Artwork Solutions
INDEGENE LABELING AND
ARTWORK SOLUTIONS
Multi-country execution of fully managed global-local labeling and artwork solutions for driving compliance and productivity
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Low ComplianceContent Inconsistencies
Decreased ProductivitySubmission Delay
CURRENT REALITIESIN LABELING
Inconsistent flow volume and improper resource
allocation
Multiple localization rules leading to content
inconsistencies
Multiple rejections and delay from the Health
Authority
High numberof handshakes across
markets
Manual interventionsand low adoption
of technology
Disparate information in different systems across
the organization
Traditional Labeling-Artwork processes are inherently inefficient with highly intense manual interventions and inordinate delays
Leading to Known Challenges
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INDEGENE'S FULLY MANAGED LABELING-ARTWORK SOLUTIONS
Source and Reference Label Creation/Update
Compliance Tracking and Submission Assistance
Label Comparison, Localization, and QC
Artwork Operations
LabelComparator
LabelManager
RuleEngine
LabelGenerator
Flow Engine
ComplianceMonitor
Program Management
Support the operations by program logistical support such as Central Share Point Services, Document Management, and Audit Support
Operational excellence augmented with modern technologies such as Structured Content Authoring, Artificial Intelligence, Natural Language Processing, and Machine Learning
Medical Technology
Core label creation by detection of signals and from the analysis of safety documents along with region-specific labeling expertise
Nuanced understanding of current and changing regulations implemented by skilled Medical team
Insight generation, automation, serialization, and e-labeling
Bringing in process excellence through robust governance
Medical Expertise
Fully managed solution that ensures efficient content management, streamlined workflows, and predictive compliance monitoring
FULLY MANAGEDSOLUTION
[email protected] W www.indegene.com +1 732 750 2901P +1 732 750 7990FIndegene, 150 College Rd W, Suite 104, Princeton, NJ 08540
OUTCOMESIN THE REAL WORLD
Decrease in overall label update
processing time
>40%Increase in
productivity
>32%
Eliminate unpredictable delays, better-planned capacity
Harmonized labels across markets with consistent safety information
Capacity Management Content Management
INCREASED COMPLIANCE. IMPROVED PRODUCTIVITY.
Timeline compliance consistently across months and years
100%