Company Core Data Sheet — the single source of safety truth.
The CCDS is the controlled, company-owned document from which every local label (USPI, SmPC, PIL, Product Monograph) is derived. Alnexia authors, maintains and governs CCDS portfolios for global Marketing Authorisation Holders.
What we deliver
New CCDS authoring
Build CCDS from clinical study reports, PSURs/PBRERs and CDS templates aligned to CIOMS guidance.
Periodic review
Scheduled reviews aligned to PSUR/PBRER cycles, signal management outputs and aggregate safety reports.
Change control
Structured CCDS change requests, impact assessments and Label Review Board (LRB) governance.
Source referencing
Every safety statement linked back to a verifiable clinical or post-marketing source.
Global rollout planning
Region-by-region implementation timelines, regulatory commitments and overdue tracking.
Gap analysis vs local labels
Detect divergence between CCDS and SmPC/USPI/PIL/PM, with remediation backlog.
Why the CCDS matters
The CCDS is the spine of a Marketing Authorisation Holder's labeling system. It consolidates safety, efficacy and use information that the company believes should appear in every market's product information — subject to local regulatory acceptance.
A weak CCDS process produces divergent local labels, missed safety updates and inspection findings. A strong CCDS process turns one safety decision into 60+ harmonised local labels on a controlled schedule.
How Alnexia runs a CCDS engagement
- Baseline: portfolio audit, CCDS health-check, divergence map vs local labels.
- Author / refresh: draft against CIOMS-aligned template with full source referencing.
- LRB governance: facilitate Label Review Board with safety, regulatory, medical and legal stakeholders.
- Implementation tracker: regional commitments, due dates, status to closure.
- Periodic review: PSUR/PBRER-aligned cycle, signal triage, version control and audit trail.
Artefacts you receive
- Approved CCDS (Word / XML)
- Source reference pack per statement
- Label Review Board minutes & decisions
- Local-label divergence matrix
- Implementation tracker & dashboard
- Periodic-review report & change log
Sourced from regulators and industry leaders
- CIOMS Working Group III/V — Core Data Sheets — CIOMS guidance
- EMA — Product information requirements — European Medicines Agency
- ICH E2C(R2) — PBRER — ICH
Ready to scope this work?
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