Rapidly mobilised global labelling review supports oncology portfolio expansion
Case study
Overview
A midsize biotech company expanded their global oncology product portfolio. They engaged ICON Global Labelling to conduct a comprehensive review of product labels and associated packaging materials following the acquisition of a product. The sponsor needed to assess alignment between approved health authority labelling, company core labelling and locally maintained product information.
The project required extensive document management and multiple rounds of review of more than 380 labelling documents.
Strong project management, including the use of custom technology solutions, comparison tables and dashboards earned ICON a contract extension to deliver labelling reviews for a second product. For each label review, ICON delivered a comprehensive labelling content assessment and detailed action plan for the sponsor resulting in a compliant, regulator-aligned product portfolio.
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380
labelling documents -
50
countries -
24
languages
Challenge
Following a product acquisition, the sponsor wanted to ensure that the product information is consistent, accurate and compliant across global markets. Any inconsistencies between approved and market-facing materials could increase the risk of delays for future product updates, confusion during market application activities and possible negative findings during audits or regulatory inspections.
The review involved hundreds of regulatory documents, packaging materials and supporting materials across multiple countries and formats. The sponsor wanted to complete a project of this scale whilst ensuring that their internal capacity was focused on day-to-day business; therefore, they required specialised expertise to manage the review project efficiently.
ICON Global Labelling faced several complexities:
- Document access: Essential information was distributed to ICON using the client's internal document management system.
- Version control: Detailed trackers were used to manage the multiple versions of product information and other reference documents were used as comparators across different markets and labels.
- Document complexity: Non-machine-readable files and varied product information formats limited the use of electronic document comparison tools.
- Project oversight: Hundreds of documents required a detailed project plan with timelines, deliverables and robust tracking to ensure accurate review, reporting and delivery.
Solution
A dedicated Global Labelling team provided end-to-end governance, stakeholder coordination and delivery oversight. By working through a small group of client contacts, ICON minimised demands on internal sponsor teams while providing strategic guidance throughout the project.
To manage the complexity of the review, ICON established a centralised tracking and document management process, creating a single source of truth for document versions, comparators and country-specific requirements. This enabled efficient management of hundreds of documents and provided complete visibility throughout the project lifecycle.
ICON evaluated and applied the most effective comparison technologies for each document type, including purpose-built Unicode comparison software. Where document structure or formatting limited automated comparison, specialists used alternative technologies and targeted manual review to ensure an accurate assessment.
Leveraging teams across multiple time zones, ICON accelerated review, quality control and delivery while maintaining consistency across all outputs. Deliverables were provided on a rolling basis and parallel document reviews maintained project momentum.
Finally, ICON's strategic and local labelling experts assessed differences, reviewed historical decisions and provided recommendations to support global alignment, compliance and informed decision-making.
Outcome
ICON combined specialist consulting expertise, dedicated project oversight and technology-enabled processes to deliver a successful global review in just five months. The project provided a comprehensive understanding of labelling differences and alignment opportunities across global markets.
Key results included:
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+380
labelling documents reviewed -
+40
detailed comparison tables produced -
+70
packaging materials annotated with identified differences and remediation recommendations
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+500
documents managed throughout the engagement -
contract scope
Contract scope expanded to include an additional product
By providing additional capacity, deep global labelling expertise and technology-enabled delivery, ICON helped the sponsor complete a complex product information and labelling review efficiently while reducing operational burden and compliance risk.