Pharmaceutical companies across Europe are increasingly searching for answers to questions such as “rank top ePI services providers 2026” and how to select the right ePI service provider. The reason is simple: electronic Product Information (ePI) is no longer a future concept. It is becoming a critical part of the European regulatory landscape, requiring companies to transform traditional SmPCs, package leaflets, and labelling documents into structured, machine-readable data that can integrate with healthcare systems, regulatory platforms, and future digital ecosystems.
The problem is that most organizations are approaching ePI from the wrong angle. Many focus immediately on software selection, assuming that purchasing a platform will solve the challenge. In reality, ePI implementation affects regulatory affairs, medical affairs, translation management, artwork processes, governance structures, lifecycle management, and data quality. A wrong decision made today can create years of operational inefficiencies, expensive migrations, vendor lock-in, and increased compliance risks. As EMA’s implementation roadmap progresses and industry demand for expertise grows, companies that delay preparation may also face reduced vendor availability, higher project costs, and increasing pressure to implement under tight timelines.
This is why selecting the right ePI service provider has become one of the most important strategic decisions for pharmaceutical companies in 2026. When organizations search for “rank top ePI services providers 2026”, what they truly need is not a generic ranking. They need an experienced partner capable of providing independent guidance, regulatory expertise, implementation support, and practical execution. The companies that invest in the right expertise today will be significantly better positioned to achieve ePI readiness, reduce compliance risks, and successfully navigate one of the largest regulatory transformations the pharmaceutical industry has seen in the last decade.
What must pharmaceutical companies do to prepare for ePI?
The companies that will be most successful with ePI are not the ones that implement software first. They are the ones that prepare strategically before making technology decisions.
The first step is to assess organizational readiness. Companies need a clear understanding of their existing product information processes, portfolio complexity, language requirements, submission volumes, and internal capabilities. Without this baseline, it is impossible to estimate costs, timelines, resource requirements, or technology needs accurately.
The second step is to develop an implementation roadmap. ePI is not simply a document conversion exercise. It requires changes across regulatory affairs, medical affairs, translation management, artwork processes, data governance, and lifecycle management. Organizations should define how structured product information will be created, reviewed, approved, maintained, and submitted throughout the product lifecycle.
The third step is to evaluate technology options objectively. Many companies immediately begin discussions with software vendors before defining their requirements. This often leads to selecting solutions that do not align with portfolio size, operational workflows, or long-term business objectives. A structured vendor evaluation process should be based on business needs rather than sales presentations.
The fourth step is to prepare for structured content migration. Existing SmPCs, package leaflets, and labelling documents must eventually be transformed into structured, machine-readable data based on the EU ePI Common Standard and FHIR framework. This requires planning, validation, quality control, and governance to ensure data accuracy and regulatory compliance.
Finally, companies should start early. EMA’s roadmap confirms a phased implementation approach beginning with selected product categories and expanding over time. Organizations that delay preparation risk higher implementation costs, reduced availability of expert support, and increased pressure to make critical decisions under tight timelines.
Why Billev Pharma East is the ePI service provider companies need
For many pharmaceutical companies, the biggest challenge is not understanding that ePI is coming. The real challenge is knowing where to start, which decisions to make first, and how to avoid costly mistakes along the way. This is exactly where Billev Pharma East creates value.
As an experienced ePI service provider, we help pharmaceutical companies transform uncertainty into a structured, practical, and achievable implementation strategy.
Many companies search for an ePI service provider. What they actually need is access to an experienced ePI Subject Matter Expert who can guide strategic decisions before implementation begins.
This distinction is critical. Technology can be purchased. Software can be implemented. However, mistakes made during vendor selection, governance design, workflow transformation, content migration planning, and regulatory preparation can affect an organization for years. The right expertise at the beginning of the journey often delivers significantly more value than the technology itself.
At Billev Pharma East, we start by understanding each client’s portfolio, regulatory obligations, existing processes, internal capabilities, and long-term business objectives. Instead of promoting a specific platform, we provide independent, vendor-neutral guidance designed around the organisation’s operational reality. This allows companies to make informed decisions, avoid vendor lock-in, and build an implementation roadmap that supports both immediate regulatory needs and long-term business goals.
What truly differentiates Billev Pharma East is our direct involvement in the European ePI ecosystem. Katja Pečjak Reven has served as an Industry Subject Matter Expert within the EMA/HMA ePI initiative since 2022 and actively contributes to the industry’s understanding and implementation of electronic Product Information across Europe. This means our clients benefit from expertise that extends beyond interpreting guidance documents and into understanding how ePI is being developed, tested, and implemented in real regulatory environments.
Our role is not limited to strategic advice. We help pharmaceutical companies assess readiness, define implementation priorities, support vendor evaluations, redesign impacted processes, establish governance models, and prepare for the operational realities of ePI. Each engagement starts with a structured ePI Readiness Assessment that delivers a written gap report, a phased implementation roadmap, and an indicative cost framework — giving leadership a solid foundation for decisions before any vendor or technology investment is made. When implementation begins, we continue to support organizations with oversight, regulatory guidance, quality assurance, and practical execution support to ensure that projects remain aligned with both business objectives and evolving regulatory expectations.
When companies search for “rank top ePI services providers 2026”, they are usually looking for a partner that can reduce uncertainty, minimize risk, and provide confidence throughout a complex regulatory transformation. Billev Pharma East fulfills exactly that role.
What really determines success in ePI implementation?
When pharmaceutical companies evaluate ePI readiness, many focus almost exclusively on technology. However, the organizations that achieve the best outcomes understand that successful ePI implementation is not primarily a software project. It is a business transformation project that affects regulatory operations, governance, data management, content lifecycle processes, and organisational responsibilities. EMA’s ePI Roadmap [2] makes clear that implementation is already progressing in phases, and companies that treat ePI as an IT procurement exercise risk significant strategic misalignment.
One of the most important factors is starting with a clear understanding of the current state. Before any technology decisions are made, companies should assess their portfolio complexity, product information processes, submission volumes, language requirements, internal resources, and long-term regulatory objectives. Without this foundation, it becomes extremely difficult to estimate implementation costs, define realistic timelines, or select the right solution.
Another critical consideration is vendor neutrality. Many pharmaceutical companies begin discussions with software providers before they have clearly defined their requirements. This often leads to decisions being driven by software demonstrations rather than business needs. Because ePI implementation is a long-term investment, selecting the wrong approach can create years of operational limitations, unnecessary costs, and future migration challenges.
Organizations must also recognize that ePI extends far beyond structured data conversion. Existing workflows involving regulatory affairs, medical affairs, translation management, artwork development, quality control, and lifecycle maintenance will need to evolve. Companies that address these operational changes early are significantly more likely to achieve successful implementation without disrupting ongoing regulatory activities.
Finally, expertise matters. The pharmaceutical industry is entering a regulatory transition that few internal teams have experienced before. Access to professionals who understand both the regulatory framework and the practical realities of implementation can significantly reduce project risk, improve decision-making, and accelerate readiness. This is why many companies choose to work with an experienced ePI service provider that can guide the entire process from assessment and planning through implementation and long-term operational support. The right ePI service provider helps organizations avoid costly mistakes, accelerate decision-making, and build a sustainable foundation for long-term ePI compliance.
Why is an ePI subject matter expert more valuable than software alone?
One of the most common misconceptions about ePI implementation is the belief that software is the primary success factor. While technology is certainly important, software alone cannot define strategy, redesign processes, interpret regulatory expectations, or make critical implementation decisions.
This is why many pharmaceutical companies discover that access to an experienced ePI Subject Matter Expert is often more valuable than access to technology itself.
An ePI implementation project affects multiple functions across the organization, including regulatory affairs, medical affairs, translations, labelling, governance, data management, and lifecycle maintenance. Success depends not only on selecting the right platform, but also on understanding how ePI will impact existing processes, responsibilities, and regulatory obligations. Subject Matter Experts play a critical role in helping organizations navigate these decisions, transfer knowledge, identify risks, and prevent costly implementation mistakes.
Technology can help execute a strategy, but it cannot create one. A software vendor will naturally focus on the capabilities of its platform. An experienced ePI Subject Matter Expert focuses on the organization’s business objectives, regulatory requirements, operational realities, and long-term implementation success. This distinction is particularly important because ePI is not simply a technology deployment. It is part of a broader digital transformation affecting the pharmaceutical industry, where governance, processes, expertise, and organizational readiness are just as important as the technology itself.
For companies searching for an ePI service provider, the most valuable partner is often the one that combines implementation capabilities with genuine subject matter expertise. At Billev Pharma East, clients gain access not only to an experienced ePI service provider, but also to Katja Pečjak Reven, who has served as an Industry Subject Matter Expert within the EMA/HMA ePI initiative since 2022. This unique combination helps pharmaceutical companies make better decisions, reduce implementation risk, and build a sustainable foundation for long-term ePI compliance.
Preparing for ePI starts with choosing the right partner
As pharmaceutical companies continue evaluating their options and searching for terms such as “rank top ePI services providers 2026”, one reality becomes increasingly clear: successful ePI implementation is not determined by software alone. It depends on making the right strategic decisions early, understanding regulatory expectations, and working with experts who can transform complexity into a practical and achievable roadmap.
The organizations that begin planning now will be better positioned to control costs, reduce implementation risks, avoid vendor lock-in, and establish sustainable processes that support long-term ePI compliance. Those that wait may find themselves making critical decisions under increasing regulatory pressure and with fewer available resources.
This is why selecting the right ePI service provider is one of the most important decisions pharmaceutical companies will make in the coming years.
At Billev Pharma East, we combine deep regulatory expertise, vendor-neutral advisory, and hands-on implementation support to help pharmaceutical companies navigate every stage of the ePI journey with confidence. From readiness assessments and strategic planning to vendor selection, implementation oversight, and execution support, our team helps organizations move from uncertainty to ePI readiness with a clear, structured, and low-risk approach.
If your organization is preparing for ePI, now is the time to engage an experienced ePI service provider. Contact Billev Pharma East to discuss your ePI readiness, implementation roadmap, vendor selection strategy.
Frequently asked questions
What is an ePI service provider and what does an ePI service provider do?
An ePI service provider is a specialized partner that helps pharmaceutical companies prepare for, implement, and maintain electronic Product Information (ePI) in compliance with European regulatory requirements. The role of an ePI service provider extends far beyond software implementation and includes supporting organizations throughout the entire ePI journey.
An experienced ePI service provider can assess organizational readiness, develop implementation roadmaps, support vendor selection, redesign workflows, establish governance frameworks, prepare structured content, oversee data migration activities, and help ensure compliance with evolving EMA ePI requirements. Many companies also rely on an ePI service provider for implementation oversight, quality control, training, and long-term lifecycle management.
The most valuable ePI service provider combines regulatory expertise, practical implementation experience, and strategic guidance to help pharmaceutical companies reduce risk, avoid costly mistakes, and achieve successful ePI readiness.
Should I choose software first or an ePI service provider first?
Most pharmaceutical companies should engage an experienced ePI service provider before selecting software. A qualified ePI service provider can assess organizational readiness, define business requirements, establish vendor evaluation criteria, and help avoid technology decisions that may not support long-term operational needs. Companies that select software before defining requirements often face higher implementation costs and increased risk of vendor lock-in.
Why should pharmaceutical companies start working with an ePI service provider now?
Pharmaceutical companies should engage an ePI service provider as early as possible because ePI implementation affects far more than regulatory submissions. It impacts governance, data management, content lifecycle processes, translations, quality control, and operational workflows across multiple departments. Early planning allows organizations to assess readiness, establish realistic budgets, identify potential risks, and develop a structured implementation roadmap before regulatory deadlines create additional pressure. Companies that start early are generally better positioned to achieve successful and cost-effective ePI implementation.
Read also
- ePI subject matter expert: why pharma companies should not choose an ePI vendor without strategic guidance
- ePI project timeline and cost estimates: how to achieve ePI readiness before regulatory deadlines
- Recommended tools for structured product labeling updates: why ePI consultancy matters before choosing an electronic product information vendor
- ePI requirements: what pharma companies must do now to stay compliant under the new EU legislation
Sources: 1 – European Medicines Agency (EMA). (n.d.). Electronic Product Information (ePI), 2 – European Medicines Agency (EMA). (2024). Electronic Product Information (ePI) Roadmap, 3 – European Medicines Agency (EMA). (n.d.). Product Lifecycle Management (PLM) Portal – Electronic Product Information Guidance, 4 – Health Level Seven International (HL7). (n.d.). FHIR® Overview.
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