The global shift toward electronic Product Information (ePI) is accelerating, driven by regulators across Europe, Canada, Asia, LATAM, and the Middle East. With the EMA preparing to mandate FHIR‑based ePI, pharmaceutical companies are experiencing mounting pressure to modernize their labeling capabilities. Digital transformation, once a long‑term consideration, has now become a near‑term operational requirement.
In this early phase of adoption, outsourcing XML to ePI conversions offers a practical and efficient pathway forward. It allows companies to maintain focus on regulatory submissions and ongoing lifecycle management while relying on specialized partners to deliver compliant, high‑quality structured content.
This approach minimizes disruption, accelerates readiness for emerging global requirements, and enables participation in key pilots without the need for major upfront investments. Outsourcing provides the breathing room necessary to develop internal expertise at a sustainable pace.
That is where PharmaLedger and Glemser come in. We have partnered to offer a unified, turnkey model for electronic leaflet conversions. In this collaboration, Glemser manages XML to ePI conversion activities, ensuring compliance and governance, while PharmaLedger provides the validated technology platform (AstraLabel™) which powers the workflow and delivers electronic product information to Patients and Healthcare Practitioners across the world (readiness in 46 countries and in 29 languages).
A major challenge companies across the EMA region are now facing is the sheer volume of content that must be converted and uploaded in a short period of time. The transition to FHIR-based ePI requires organizations to process thousands of leaflets simultaneously, often across dozens of markets and product portfolios. Most regulatory and labeling teams simply do not have the internal capacity or infrastructure to handle such a surge.
Compounding this is the need to transform existing multilingual paper leaflets into single, structured electronic leaflets, a task that demands both technical expertise and precise content formatting. PLA’ AstraLabel™ & Glemser can support this high-volume – format specific – effort through scalable conversion services, ensuring companies remain compliant without overloading their internal teams.
Together, AstraLabel™ & Glemser’s offering enables pharma companies to adopt digital labeling efficiently, without building their own technology stack and maintaining lower costs. This combined approach delivers:
Importantly, outsourcing does not mean relinquishing control. PharmaLedger Association (PLA) ensures that companies retain full authority over validation, quality decisions, and final approvals. Rather than replacing internal governance, outsourcing extends organizational capacity while preserving oversight.
As labeling volumes grow and digital transformation matures, companies can transition smoothly into PLA’s AstraLabel™, through different deployment models — from decentralized operations (AstraLabel™ CORE) to centralized global enterprises (AstraLabel™ SOLO) and on‑premise environments for strict data control (AstraLabel™ EDGE). With the integration of Glemser’s XML Conversion and AstraLabel™ Platform capabilities, PharmaLedger is able to deliver to its customers:
Together, outsourcing XML Conversion to Glemser & AstraLabel™ represent a balanced path forward. Companies can meet immediate XML and FHIR compliance needs through outsourcing while gradually building the internal digital infrastructure required for scale. The joint PLA + Glemser offering removes complexity from the transition, ensuring that organizations of ALL SIZES can confidently navigate the shift toward structured, digital, and patient‑centric product information.