1. REAL-WORLD CASE STUDY #1
Authoring of CDS: Mature Products across TAs
100% Compliant
Timelines & Quality
99.5%
Right First Time Score
Multi-year
Engagement
120+ CDS
Created/QCed
80+ COs
Created/updated
Business Need
Solution
Outcomes
Develop CDS and ensure consistency of local labels with the core data for mature products across multiple therapeutic areas
Prepare comparison tables and the summary of deviations
Reference search and authoring CO/tailored CO if required to support the changes
Team trained on client specific SOPs and WIs
Labeling and medical writers and reviewers; quality reviewer; scientific editors; project manager
Constituted robust communication and escalation channels
Established Governance layer for monitoring and improvement
120+ CDS created/QCed
80+ COs created/updated
≥ 99.5% Right first time score with consistency
100% compliance to Client timelines
3rd year of engagement with current team size of 32 FTEs
Scope expansion to local label update/QC, labeling comparison and alignment

2. REAL-WORLD CASE STUDY #2
Regional Hub for End-to-End Labeling Support
100% Compliant
Timelines & Quality
1100+ COs authored/updated
100+
Markets covered
7000+
Label compared &
updated/ created
> 25,000
Artworks delivered
Business Need
Solution
Outcomes
Critically low regional compliance levels observed during client’s internal audit check
Single strategic partner for managing time- critical labeling remediation activities
Large volume of labels to be updated across 350 plus product profiles and markets covering Asia, Europe, Africa and LATAM
Retrospective comparison and assessment of local label v/s CCDS to ensure consistency of information and regularizing submission to HAs
Multi geographic COE setup for flexibility with regional understanding and language expertise
25FTEs (labeling & artwork experts, PM) deployed in 6 weeks
Seamless integration of client systems & processes
Multiple work streams that included authoring, updating, translating, proofing, alignment of local labels and artwork and pack management
70+ dedicated resources
Zero observations during QC and Audit
100% regional compliance maintained for all the markets
Supported with backlog clearance ~1000 labels in 2 months
4th year of engagement: evolution of partnership into an end to end global labeling management

3. REAL-WORLD CASE STUDY #3
Partner for Client Labeling Operations
100% Compliant
Timelines & Quality
Multi-year
Engagement
<0.5 Error Rate
Right First Time Score
2500+ Local Labels
Updated
Comparisons
Performed
2000+ COs
Created/updated
Business Need
Solution
Outcomes
Large volume of retrospective labels to be aligned to the latest CCDS and safety information by providing justifications
Label updates, Clinical overviews and Artwork remediation activities across >120 markets
End-to-End Project Management
40+ trained labeling experts on-boarded within 6 weeks with complete transition of work
Team trained on client specific SOPs and WIs
An Onsite Project Manager placed for better communication and reachability
Proprietary platform deployed to coordinate/ track/ trend/ report activities with nearly 150 local affiliates
Team size increased to 65 FTEs within 2 years
Scope expansion to include consumer and nutritional products

4. REAL-WORLD CASE STUDY #4
Label QC and Proofreading Engagement
100%
Regulatory Compliant
1100+ COs authored/updated
99.9%
first time right
2000+
Labels QCed
> 4000
Artworks proofread
Business Need
Solution
Outcomes
High-volume local label updates required a QC review to ensure consistency and accuracy
Client was looking for cost-effective model to support Quality check, Editorial review and Proof-reading of CDS, Local Product/ Patient Labels and Artwork
The expected volume to be delivered was >2000 labels and >3000 artworks per year
Strategic offshore hubs at Bangalore and Shanghai, leveraging geographical diversity and scale
Centralized teams of 5 Labeling reviewer and 10 proofreader to manage multiple geographies
CDS reviewed for consistent medical information across different sections, consistency in language, style and formatting
Workshops with client to stay ahead of global regulatory trends and new labeling technology
Expanded to include multiple other global destinations through a shared-service model
4th Year of engagement with labels proofread per year