Label Authoring & Updates
Creation and revision of Prescribing Information (PI), SmPCs, Medication Guides (MGs), Product Monographs and Patient Information Leaflets (PILs) to regional templates.
Regulatory Labeling
CCDS to local label, in lockstep.
Comprehensive support for global and local drug product labeling — from creation and maintenance through compliance and lifecycle management. Built for CCDS, SmPC, USPI, PIL, Medication Guides and Product Monographs.
CCDS Development & Maintenance
Company Core Data Sheet authoring, periodic review and global rollout. Track every safety statement back to a sourced reference.
Label Change Control
Structured change-impact assessments, label review boards, deviation handling and version-controlled approval workflows.
Gap Analysis vs CCDS
Side-by-side comparison of local labels against the CCDS, with discrepancy logs, justifications and remediation tracking.
Regional Implementation
USPI, EU SmPC/PIL, Canadian Product Monograph, MENA, APAC and LATAM local labels — one team, every market.
Translations & QRD Compliance
EMA QRD-compliant translations across all 24 EU languages, with linguistic review and readability user-testing coordination.
Periodic Label Review
Scheduled label health-checks aligned to PSUR/PBRER cycles, signal management outputs and aggregate safety reports.
Label Tracker & Reporting
Real-time visibility across the portfolio: implementation status, regulatory commitments, due dates and overdue items.
Deep dives
Explore each labeling capability
CCDS authoring & maintenance
Company Core Data Sheet — the master safety document driving every local label.
EU SmPC, PIL & Labelling
QRD-compliant Annex I/IIIA/IIIB authoring across all 24 EU languages.
USPI, MedGuide & PPI
PLR- and PLLR-compliant US prescribing information and patient labeling.
Label change control & LRB
Governance, change impact assessment and audit-ready change history.
How we work
A controlled, auditable labeling cycle
01
Source
CCDS, safety signals, regulatory commitments.
02
Author
Local labels drafted against regional templates.
03
Review
Label review board, QC and tracked changes.
04
Submit
Regulatory submission and implementation tracking.