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:
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
For more information, download Global Labeling solution data sheet.