As health authorities around the world move steadily toward structured labeling standards like electronic Product Information (ePI), Pharma Ledger, and Structured Product Monograph (SPM), mid-to-large-sized pharmaceutical companies are asking a critical question: How do we support global requirements without overextending our internal teams or making irreversible investments?
For many, the answer is to partner with a trusted vendor.
Why Vendors Make Sense for Early-Stage ePI Programs
Complying with global structured labeling mandates is a heavy lift. With the European Medicines Agency (EMA) preparing for broader ePI rollout, Health Canada formalizing the SPM structured XML submission format, and other markets like Saudi Arabia and Brazil gaining momentum, regulatory and labeling teams are under increased pressure. These teams are already busy managing a full load of submissions, change controls, and projects. Adding structured labeling without increasing headcount can create bottlenecks and compliance risks.
That is why many pharma companies are choosing to outsource ePI conversions in the near term. This model offers several advantages:
- Teams can evaluate vendor capabilities before committing to long-term changes
- Internal resources remain focused on existing priorities and obligations
- No need to hire and train new staff before ePI is fully understood and confirmed
Importantly, outsourcing gives companies breathing room. It provides a way to begin ePI work without committing prematurely to a specific system, workflow, or architecture.
From Not Enough to Too Much: The Volume Challenge
Initially, many companies feared they might not meet minimum agreed-upon volume for ePI conversions with their outsource vendor. That concern has shifted.
Now, as more health authorities signal upcoming requirements, the worry is no longer about too little volume. It is about too much. What happens when you are faced with converting thousands or even tens of thousands of labels?
At that scale, conversion costs add up fast. Labeling, regulatory, and procurement teams are beginning to see the budget implications. The issue is not just price per document. It is sustainability.
That is why selecting the right partner up front is so important. A capable vendor will do more than process conversions. That vendor will help you build a bridge to an in-house model.
Choose a Vendor That Can Also Be Your Implementation Partner
The ideal vendor can support high-volume outsourced conversions today and help you bring the process in-house tomorrow. This model gives companies control over the pace and structure of their transition.
A dual-role vendor should:
- Deliver accurate, high-quality conversions at scale
- Maintain data in structured, secure formats aligned with FHIR, Pharma Ledger, Structured Product Labeling (SPL), and SPM
- Implement its software inside your organization as readiness increases
- Train your internal teams while continuing to manage conversion overflow
- Support parallel workflows until your team is fully onboarded
This hybrid approach allows for continuity, reduces long-term vendor lock-in, and enables knowledge transfer while real work gets done.
RELATED: 6 Things to Look for When Choosing an AI-based Labeling System
The Right Time to Build is While You Convert
Outsourcing structured labeling work should not be a stopgap measure. It can be the first phase of a scalable, sustainable structured content strategy. When you work with a vendor that also delivers the system, your conversion work becomes a proving ground. You learn what works, refine the process, and build internal buy-in based on real results.
By the time the mandate hits, you are not scrambling. You are prepared.
At Glemser, we provide both high-volume ePI conversion services and the systems that support long-term internal scale. Our platform is built for structured content, and our team is ready to support your evolution from outsource to in-house on your timeline.
Let’s talk about a model that works for today and tomorrow. Contact Glemser to get started.