Global Pharmaceutical Labeling

Global Labeling Challenges

Pharmaceutical companies spend a significant amount of time managing product labeling documents such as Package Inserts (PIs), Summaries of Product Characteristics (SmPCs), and Core Data Sheets (CDSs). The same information is often duplicated in multiple documents for various product strengths, dosage forms and presentations, resulting in a large set of labeling documents that are difficult to manage and keep synchronized.

Meanwhile, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are implementing an evolving set of rules regarding the electronic submission of labeling content. The FDA requires the submission of XML labeling content in Structured Product Labeling (SPL) format and the EMA requires pharmaceutical companies to submit product information documents in QRD-compliant format.

As a result, life sciences companies have a double challenge. In the short term, they need to put in place systems and processes to ensure compliance with emerging standards. In the long term, they need to make strategic decisions to reduce the complexity and cost of managing their global labeling content.

Glemser's Labeling Solutions

Over the past 10 years, Glemser has implemented global labeling solutions for many pharmaceutical companies.  Our products are used by over 10,000 users in more than 100 countries.  We have gained a significant amount of experience implementing and supporting production-grade labeling solutions and have reflected these experiences in our base xmLabeling product.

xmLabeling can manage the complete set of global labeling content. Glemser provides specialized xmLabeling-based products and services, including:

• xmLabeling for SPL – to enable life sciences companies to create and manage US content of labeling and drug listing information, NDC Labeler Code Requests, and Establishment Registrations in SPL format
  
• xmLabeling for EU submissions – to enable companies to manage European centralised procedures in QRD-compliant format and achieve operational efficiencies through the re-use of labeling content and integration with translation management systems and services providers
• Clinical  Labeling Development System – to enable companies to improve the speed in which clinical labeling documents are created, managed, and published, and to ensure that all labeling documents used in clinical trials comply with country-specific regulatory requirements
  
• SPL Conversion Services – to allow companies to author MS Word-based product information documents and utilize Glemser products and services to convert these documents for submission to the health authorities

Glemser offers a complete set of implementation services for xmLabeling projects.  We can leverage our software products, implementation accelerators, best practice configurations, global labeling domain experience and technical XML expertise to help you with any aspect of your global labeling
initiative.

For more information, download Global Labeling solution data sheet.