Pharmaceutical companies across Europe are increasingly searching for answers to the question: “which vendors support structured product labeling to ePI?” But most organizations are already approaching the problem from the wrong angle. The real challenge is not finding software. The real challenge is surviving the operational complexity that comes with ePI implementation — a challenge that often requires the guidance of an experienced ePI subject matter expert long before any vendor selection begins.

Electronic Product Information (ePI) introduces a structured digital layer for SmPCs, package leaflets, and labelling based on HL7 FHIR standards. What sounds like a regulatory modernization project quickly becomes a major operational burden inside pharmaceutical companies. Regulatory teams suddenly need to manage structured content alongside existing PDF and paper formats. Medical, artwork, translation, submission, and digital teams all become dependent on completely redesigned workflows running in parallel across multiple markets. Many companies discover too late that their existing regulatory workflows were never designed for structured data governance at this scale. As implementation pressure grows, internal teams become overloaded with parallel review cycles, fragmented approval processes, inconsistent data structures, and increasing compliance risk. This is where companies start feeling the pressure.

Many organizations underestimate how difficult it is to migrate hundreds or thousands of approved product information documents into structured formats while still maintaining daily regulatory operations. Internal teams are often expected to evaluate vendors, redesign governance, validate structured data, coordinate multilingual content, and prepare for future EMA requirements — despite having no previous ePI implementation experience. The result is confusion, overloaded teams, delayed submissions, costly remediation work, and long-term vendor lock-in decisions that become extremely difficult to reverse later.

This is exactly why working with an experienced ePI subject matter expert has become critical before selecting any ePI platform. Companies searching for “which vendors support structured product labeling to ePI” often do not actually need software first. They need an experienced regulatory advisor who understands how to structure the entire transformation process, evaluate operational readiness, prevent expensive implementation mistakes, and build a realistic roadmap that protects both compliance and business continuity.

What pharmaceutical companies must do before choosing an ePI vendor

Pharmaceutical companies preparing for ePI implementation cannot afford to treat this as a simple IT procurement project. Before selecting any platform, organizations first need to understand how electronic product information will affect their entire operational ecosystem. ePI introduces structured, machine-readable product information based on HL7 FHIR standards designed for integration across healthcare systems, multilingual environments, and future digital regulatory processes.

The first step companies must take is assessing their internal readiness. Most organizations already operate under significant pressure from regulatory submissions, lifecycle management, artwork updates, translations, and compliance obligations. Adding structured ePI requirements on top of existing operations without a clear roadmap creates immediate operational risk. Companies therefore need a detailed evaluation of their current product information workflows, portfolio complexity, submission volumes, multilingual processes, governance structures, and internal resource capacity before making any technology decision. This assessment should also include structured product labeling readiness, FHIR data governance capabilities, and long-term scalability of the future ePI implementation roadmap.

The second critical step is defining implementation strategy before vendor discussions begin. This is where an experienced ePI subject matter expert becomes essential. Companies need someone who understands how to redesign workflows across regulatory affairs, medical, translation, artwork, digital systems, and quality oversight while ensuring alignment with evolving EMA expectations. Without this guidance, vendor evaluations often focus only on software functionality instead of long-term operational fit, scalability, migration complexity, integration risks, and regulatory sustainability.

Companies must also understand that not every document can simply be converted automatically into structured FHIR data. Human review, validation, governance oversight, and quality control remain critical parts of successful implementation. This means organizations need realistic timelines, phased migration planning, training strategies, and implementation governance before any platform is selected.

The companies that prepare strategically today will avoid rushed decisions, overloaded teams, and costly remediation projects later — especially once broader mandatory ePI implementation accelerates across the EU market. Based on typical implementation experience, a structured readiness programme covering gap assessment, governance design, and vendor selection requires 6 to 12 months before any migration work begins.

Why companies choose Billev Pharma East as their ePI subject matter expert

Most pharmaceutical companies do not fail because they lack motivation to implement ePI. They fail because they underestimate how operationally disruptive the transition becomes once implementation actually starts. Internal teams suddenly face vendor evaluations, workflow redesign, structured data migration, multilingual coordination, governance changes, validation requirements, and evolving EMA expectations — all while daily regulatory operations still need to continue without delays.

This is exactly where Billev Pharma East becomes critical.

At Billev Pharma East, we act as an independent ePI subject matter expert and strategic implementation partner focused entirely on protecting pharmaceutical companies from expensive mistakes, rushed vendor decisions, and failed implementation strategies. Unlike software providers, we do not push a specific platform. Our role is vendor-neutral advisory combined with real pharmaceutical operational expertise.

What makes our approach different is that we start with the company itself — not with the software. We assess the client’s portfolio complexity, regulatory footprint, submission volumes, multilingual requirements, existing workflows, internal systems, and operational readiness before any vendor discussions even begin. This allows pharmaceutical companies to understand what they truly need instead of selecting platforms based only on vendor presentations and marketing promises. It also allows companies to enter vendor discussions with a clear implementation strategy instead of relying on vendor-driven sales narratives that may not reflect long-term operational realities.

Billev Pharma East supports companies through every stage of the ePI transition. We provide readiness diagnostics, implementation roadmaps, vendor evaluation support, workflow redesign, governance guidance, team training, structured data oversight, migration support, testing, and quality control. Our broader expertise in regulatory affairs, pharmacovigilance, quality assurance, quality agreements, regulatory intelligence, digital consultancy, and regulatory data transformation allows us to manage ePI implementation within the realities of complex pharmaceutical environments — not as isolated IT projects.

Most importantly, companies gain direct access to genuine regulatory authority and industry leadership. Katja Pečjak Reven has served as an EMA/HMA ePI Industry Subject Matter Expert since 2022 and actively contributes to shaping how ePI standards are implemented across Europe. This means our clients are not relying on theoretical interpretation of regulations. They work with a team deeply connected to the actual evolution of ePI requirements at the European level.

For pharmaceutical companies searching “which vendors support structured product labeling to ePI”, the safest investment is often not choosing software first — but choosing the right ePI subject matter expert to guide the entire transformation from the beginning.

What becomes critical during ePI implementation planning

A recurring pattern across ePI programmes is the assumption that implementation begins with software selection. In practice, successful ePI transformation starts much earlier — with a clear understanding of how structured product information will function operationally across the entire organisation and what existing processes will need to change to support it.

Companies first need to define how product information will be created, reviewed, approved, maintained, translated, updated, and governed once structured ePI formats are introduced alongside existing PDF and paper-based documentation. This becomes especially important because ePI is built on HL7 FHIR standards [1], requiring interoperability across healthcare systems, digital platforms, and regulatory environments that most existing labelling workflows were not designed to support.

The complexity increases significantly in multinational pharmaceutical environments where hundreds or thousands of approved product information documents already exist across multiple languages and markets. This becomes even more difficult when companies attempt to standardize structured product labeling processes across multiple regulatory markets, languages, and legacy documentation systems simultaneously. Many companies underestimate how difficult it becomes to standardize content structures, maintain regulatory consistency, coordinate multilingual updates, and validate structured data while ongoing regulatory operations continue at full speed.

Another critical factor is governance [2]. ePI implementation affects regulatory affairs, medical affairs, artwork, quality assurance, translation management, digital systems, and submission teams simultaneously. Without clearly defined ownership, review responsibilities, escalation processes, validation controls, and change-management structures, implementation projects often become fragmented and difficult to control.

This is why implementation planning must include realistic migration strategies, phased execution timelines, internal capability assessments, workflow redesign, training programmes, and long-term operational oversight — not only technical conversion activities. Companies also need to evaluate how future regulatory changes, portfolio expansion, lifecycle management, and multilingual maintenance will impact scalability over time.

An experienced ePI subject matter expert becomes essential in this phase because companies rarely have internal teams with hands-on experience managing structured regulatory transformation projects of this scale. The goal is not simply becoming ePI compliant. The goal is building an operational model that remains sustainable, inspection-ready, scalable, and efficient long after the initial implementation phase is completed.

Why strategic ePI preparation will define long-term regulatory success

ePI implementation will reshape how pharmaceutical companies manage product information, regulatory workflows, multilingual content, and digital compliance across Europe. The companies that approach this transformation strategically — with the right governance, realistic implementation planning, and experienced guidance — will avoid the operational chaos, vendor lock-in, and costly remediation work that many organizations will face once mandatory timelines accelerate.

This is why choosing the right ePI subject matter expert becomes more important than choosing software itself.

At Billev Pharma East, we help pharmaceutical companies navigate ePI transformation with vendor-neutral advisory, regulatory expertise, and hands-on operational support designed specifically for real pharmaceutical environments. From readiness diagnostics and implementation strategy to workflow redesign, vendor evaluation, migration oversight, and structured data execution, we help organizations move from uncertainty to a clear, scalable, and inspection-ready ePI roadmap.

For companies currently asking “which vendors support structured product labeling to ePI”, the safest next step is often not selecting a platform immediately — but working with a trusted partner who understands how to make the entire transition successful from the beginning.

Companies that start preparing with Billev Pharma East today will be significantly better positioned once ePI implementation becomes operationally unavoidable across Europe.

Frequently asked questions about ePI implementation

Read also:

• ePI requirements: what pharma companies must do now to stay compliant under the new EU legislation
• Recommended tools for structured product labeling updates: why ePI consultancy matters before choosing an electronic product information vendor
• ePI project timeline and cost estimates: how to achieve ePI readiness before regulatory deadlines

Sources: 1 – European Medicines Agency. (n.d.). Electronic Product Information (ePI), 2 – European Medicines Agency. (n.d.). Product Lifecycle Management Portal: ePI guidance.

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In-article images: Freepik

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