ePI Subject Matter Expert guide – how to identify vendors that are truly ready for ePI

Many pharmaceutical companies begin their digital labeling journey by asking a seemingly simple question: which vendors support structured product labeling to ePI?

The problem is that the answer is rarely as straightforward as vendor websites and product demonstrations suggest. As regulatory expectations evolve and electronic Product Information becomes a strategic priority, more software providers are positioning themselves as ePI-ready. Yet not every platform is equipped to support future interoperability requirements, structured content management, or long-term regulatory scalability.

This creates a significant challenge for pharmaceutical organizations. A vendor may appear capable during the evaluation process, but critical limitations often emerge only after implementation begins – resulting in costly delays, unexpected customisation efforts, and technology investments that fail to support future ePI objectives.

That is why many companies involve an ePI subject matter expert before making a purchasing decision. Independent expertise can help separate genuine ePI readiness from marketing claims, allowing organizations to identify vendors that truly support structured product labeling and align with long-term business and regulatory goals.

Before deciding which vendors support structured product labeling to ePI, it is essential to understand the indicators of true ePI readiness – and the red flags that should never be ignored.

What pharmaceutical companies should do before comparing ePI vendors

Before evaluating vendor demonstrations or reviewing feature lists, pharmaceutical companies should establish a clear framework for assessing ePI readiness. Too often, vendor selection starts with product demonstrations rather than business requirements. This can lead organizations to invest in platforms that appear capable during the evaluation phase but later require extensive customization, additional validation activities, or even replacement as ePI requirements evolve. The cost of correcting a poor vendor decision can significantly exceed the cost of the initial implementation itself. This approach can lead teams to focus on attractive functionality while overlooking critical factors such as interoperability, structured content management, scalability, and future regulatory alignment. A structured internal requirements process is therefore a prerequisite, not an optional step.

Organizations should first define what successful ePI adoption looks like within their own environment. This includes identifying regulatory objectives, understanding existing labeling processes, evaluating content governance models, and determining how structured product information will be managed across the product lifecycle.

Only after these requirements are clearly documented should companies begin comparing technology providers. At this stage, an ePI subject matter expert can help translate business and regulatory expectations into practical evaluation criteria. This ensures that vendor assessments focus on long-term ePI readiness rather than short-term feature comparisons.

By establishing the right evaluation framework from the outset, organizations are far better positioned to determine which vendors support structured product labeling to ePI in a way that aligns with both current needs and future regulatory requirements.

What to look for in vendors supporting structured product labeling to ePI

Not all vendors that claim to support structured product labeling are equally prepared for the realities of ePI implementation.

For pharmaceutical companies, the key challenge is not identifying vendors that mention ePI capabilities on their websites. The real challenge is determining whether those capabilities can support long-term regulatory requirements, operational efficiency, and future scalability. One of the first areas to evaluate is structured content management. Vendors should be able to demonstrate how product information is created, maintained, reused, and updated throughout the product lifecycle. Without a strong structured content foundation, organizations may struggle to achieve the flexibility required for future ePI initiatives.

Interoperability is another critical consideration. As regulatory authorities continue to advance digital product information frameworks [4], companies should understand how a solution exchanges and manages structured data across systems and stakeholders. Organizations should also assess how vendors approach governance, change management, multilingual content, and lifecycle maintenance. A platform may appear technically capable today but become difficult to scale as regulatory expectations evolve.

Future readiness is equally important. Companies investing in ePI-related technologies should evaluate whether a vendor’s roadmap aligns with emerging industry standards and ongoing digital transformation initiatives within the pharmaceutical sector.

Organizations should also consider the long-term financial impact of their decision. Selecting an ePI vendor whose platform cannot adapt to future ePI requirements may result in expensive migrations, duplicated implementation efforts, and additional compliance risks. Vendor selection should therefore focus not only on current functionality but also on the solution’s ability to support future regulatory and business needs.These considerations often extend beyond software functionality alone. They require a clear understanding of regulatory expectations, structured content principles, and long-term business objectives. This is why many organizations engage an ePI subject matter expert to help assess which vendors support structured product labeling to ePI in a way that delivers sustainable value rather than short-term functionality.

Why vendor demonstrations often fail to reveal real ePI readiness

Vendor demonstrations are designed to showcase strengths. They highlight polished workflows, intuitive interfaces, and impressive functionality. However, when pharmaceutical companies are evaluating solutions for electronic Product Information, demonstrations rarely tell the full story.

One of the most common mistakes during vendor selection is assuming that a successful demonstration automatically translates into successful implementation. In reality, many of the factors that determine long-term ePI success are not immediately visible during a product presentation. Questions surrounding structured data management, governance models, interoperability, content lifecycle management, and future regulatory adaptability often remain unanswered until much later in the evaluation process.

This can create a significant risk for organizations that are trying to determine which vendors support structured product labeling to ePI.

A platform may appear capable when demonstrating a predefined use case, yet struggle when faced with the complexity of real-world regulatory operations. Similarly, some vendors may offer strong functionality today but lack a clear roadmap for supporting future ePI requirements as industry standards continue to evolve. The EMA ePI pilot findings [2] demonstrate that implementation readiness varies significantly across platforms, making independent assessment essential.

For this reason, pharmaceutical companies should treat demonstrations as only one part of the evaluation process. Equally important is the ability to assess how a solution will perform within the organization’s specific regulatory environment, operating model, and long-term digital strategy.

An experienced ePI subject matter expert can help organizations look beyond presentations and marketing claims to evaluate whether a vendor is genuinely prepared to support sustainable ePI adoption. This enables decision-makers to focus on long-term value rather than short-term impressions.

Why pharmaceutical companies choose Billev Pharma East for ePI vendor evaluation

Selecting a vendor is only one part of a successful ePI initiative. The bigger challenge is making sure the technology, regulatory requirements, governance model, and long-term digital strategy all work together.

This is where many pharmaceutical companies encounter their greatest challenge. They understand the importance of ePI, recognize the need for technology investment, and receive positive feedback from multiple vendors. Yet they often lack the specialized expertise required to determine which solution is genuinely aligned with future ePI requirements.

This is where Billev Pharma East becomes a strategic partner rather than just an advisor.

Unlike software vendors, we act as an independent advisory partner focused on helping pharmaceutical companies make the right strategic decisions before significant investments are made. Our role is not to promote a specific platform but to ensure that the selected solution supports future ePI requirements, operational efficiency, and long-term regulatory compliance.

What makes our approach different is our combination of regulatory expertise, digital transformation knowledge, and direct involvement in the evolution of electronic Product Information in Europe. Our team supports pharmaceutical companies with ePI strategy development, readiness assessments, governance models, structured content transformation, FHIR-based implementation planning, and vendor evaluation activities.

As an experienced ePI subject matter expert, Billev Pharma East helps organizations:

• Assess their readiness for ePI implementation
• Identify operational and regulatory gaps before technology investments are made
• Define objective vendor evaluation criteria
• Evaluate vendor capabilities against future ePI requirements
• Reduce implementation risks and costly rework
• Build a scalable roadmap for long-term ePI success

Our expertise is not based solely on theory. Billev Pharma East has actively contributed to the European ePI ecosystem through participation in the EMA/HMA ePI Pilot Project [2], where our experts have supported the practical development and implementation of electronic Product Information initiatives. Each client engagement begins with a structured ePI Readiness Assessment, delivering a written gap report, a phased vendor evaluation framework, and a prioritised list of implementation risks – all before any software contract is signed.

For pharmaceutical companies evaluating ePI technology providers, the most important decision is often not choosing a vendor first. It is choosing the right partner to help evaluate vendors objectively, understand future regulatory expectations, and build a sustainable ePI strategy. That is exactly where Billev Pharma East delivers the greatest value.

For organisations currently evaluating ePI technology providers, engaging an independent ePI subject matter expert before signing a contract can help prevent costly mistakes, reduce implementation risks, and accelerate long-term success.

Make your ePI vendor decision with confidence

Choosing a technology provider for ePI is not simply a software purchasing decision. It is a strategic investment that can influence regulatory operations, product information management, and digital transformation initiatives for years to come.

Organizations that take the time to define their requirements, evaluate vendor capabilities objectively, and focus on long-term ePI readiness are significantly better positioned to achieve successful outcomes. The goal is not just to identify which vendors support structured product labeling to ePI, but to determine which solution aligns with your organization’s future regulatory and business needs.

At Billev Pharma East, we help pharmaceutical companies navigate complex ePI initiatives with confidence – from readiness assessments and strategic planning to vendor evaluation and implementation support. Before committing to a vendor, pharmaceutical companies should ensure that every decision is based on objective expertise rather than marketing claims. An experienced ePI subject matter expert can help validate vendor capabilities, identify hidden risks, and ensure alignment with future regulatory requirements.

The organizations that achieve the greatest long-term value from ePI initiatives are typically those that invest time in vendor evaluation before signing contracts, rather than addressing challenges after implementation has already begun.

For companies navigating this process, Billev Pharma East provides independent expertise in ePI strategy, vendor assessment, readiness planning, and implementation support. By combining regulatory knowledge with practical ePI experience, our team helps pharmaceutical organizations make confident technology decisions and build a sustainable foundation for future ePI success.

Frequently asked questions

How can pharmaceutical companies determine whether a vendor is truly ePI-ready?

Evaluating ePI readiness requires more than reviewing product demonstrations or marketing materials. Companies should assess structured content capabilities, interoperability, scalability, governance support, and alignment with future regulatory requirements. Many organizations engage an ePI subject matter expert to perform an independent assessment before making a final decision.

Why is an ePI subject matter expert important during vendor evaluation?

An ePI subject matter expert helps pharmaceutical companies evaluate vendor claims objectively, identify implementation risks, and ensure that technology decisions support long-term regulatory and business goals. Independent expertise can reduce the likelihood of costly vendor selection mistakes.

When should pharmaceutical companies engage an ePI subject matter expert?

Ideally, organizations should engage an ePI subject matter expert before shortlisting or selecting a vendor. Early involvement helps establish objective evaluation criteria, identify potential risks, and improve decision-making throughout the vendor assessment process.

Sources: 1 – European Medicines Agency (EMA). (2020). Electronic product information for human medicines in the European Union – key principles, 2 – European Medicines Agency (EMA). (2024). Successful pilot paves the way for implementation of ePI, 3 – European Medicines Agency (EMA). (2025). Electronic product information (ePI), 4 – European Medicines Regulatory Network (EMRN). (2025). Electronic Product Information (ePI) Implementation Guide, 5 – European Medicines Agency (EMA). (2025). Electronic product information (ePI) pilot and next steps, 6 – European Commission & European Medicines Agency (EMA). (2025). ePI User Guides and FHIR Implementation Resources.