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

2

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

3

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%