Overview
Your label is your product's identity. We manage the lifecycle of your Prescribing Information (USPI), SmPC, and patient labeling. From safety updates to new indications, we ensure your labeling is compliant, competitive, and aligned with your Company Core Data Sheet (CCDS).
Key Features
CCDS maintenance
Labeling negotiation with FDA/EMA
Structured Product Labeling (SPL)
Promotional review (MLR)
Our Process
1
Signal Detection
Identifying need for label updates.
2
Drafting
Revising the label text and CCDS.
3
Implementation
Rolling out changes to packaging and promotion.
Project Complete & Deliverables Provided
Frequently Asked Questions
A Company Core Data Sheet (CCDS) is your internal master document containing all approved safety and efficacy information for your product. It serves as the reference for all regional labels (USPI, SmPC, etc.) and ensures global consistency. When new safety information emerges, you update the CCDS first, then cascade changes to regional labels. Without a well-maintained CCDS, global labeling becomes chaotic.
Why Choose Us
- Accurate safety communication
- Competitive claims
- Global consistency
- Compliance with formatting rules
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Contact our team to discuss your specific needs for Labeling Updates.
Schedule ConsultationWhat Our Clients Say
"A post-marketing signal required urgent labeling updates across 30 countries. Adelphi coordinated the CBE-0 submission to FDA, cascaded to EMA and Health Canada, and managed the ROW updates—all within 45 days. Our risk was contained quickly."
Dr. Andrew Thompson
Chief Medical Officer
Mid-Size Pharma
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