Skip to content
English
My AccountCart
Artwork Management

Compliant by Design: How Automation Is Reshaping Leaflet Management in Life Sciences

Alexandra Blanck

Written by Alexandra Blanck

Content Manager, Esko

In the life sciences industry, patient information leaflets are much more than just paper inserts.

In fact, they’re the lifeline for regulatory compliance, patient safety, and brand trust.

But as content complexity increases and regulatory demands evolve, managing leaflets has become one of the most error-prone, time-consuming, and manual-heavy tasks in the packaging and labeling lifecycle.

In a recent webinar, Esko Life Science experts shared how automation is paving the way for a safer, faster, and more efficient future for leaflet creation.

Here’s what they had to say.

Why Leaflets Are So Complex and Risky

Let’s face it, leaflets are deceptively complicated and risky.

It’s not just their importance that makes them so challenging. Leaflets carry critical information that must be accurate, readable, and localized for multiple markets. This makes accuracy not just a nice-to-have, but a must-have.

Additionally, leaflets often include tables, imagery, and multilingual text that must adhere to stringent regulatory formats.

As highlighted in the webinar “Forging the Path for Leaflet Automation,” leaflets may account for over 70% of an artwork team’s workload.

So what else adds to the complexity? Myriad factors, including:

Design Constraints
Leaflets are composed of dense technical content. Publishing that information while ensuring readability is a tricky balancing act.

Layout Intricacy
Layouts are anything but simple. Oftentimes, text flows across columns and wraps around tables and graphics.

Regulatory Guidelines
Regulatory guidelines are strict and must be followed exactly. That alone is complex, but when you add different requirements for font sizes, spacing, and color coding that differ by region and language – it’s a super-human effort.

Consumers Demands
It’s not just regulations that are evolving, consumers are too. Younger users expect interactive web formats, while older users may struggle with fine print, especially on folded paper leaflets.

Given this context, it’s no surprise that the current leaflet management process is a known bottleneck.

That’s also what makes it an ideal candidate for automation.

Manual Structuring, Versioning, and Multilingual Compliance

Despite the availability of digital capabilities, manual processes still dominate leaflet workflows.

In a live poll during the webinar, 62% of participants indicated they still use Microsoft Word as their primary source of truth, while another 33% rely on previously approved leaflets—typically a PDF of the printed leaflet marked up with redlines.

Only 5% reported using a structured content management system.

The result? The following pain points rear their ugly heads:

Slow Time-to-Market
Based on input from our customers, it currently takes an average of 120-180 days to update leaflet artwork. Executives aim to reduce this to 20–30 days, and Esko envisions a future where it can be done in as little as one week.

Regulatory Risk and Complexity
Meeting diverse regulatory requirements across global markets introduces countless variables. Some are as small as how a bullet point is formatted, or a table is structured. Talk about tedium.

Inefficiencies in Content Reuse
When most content changes have to be made on multiple leaflets, content isn’t being reused effectively, leading to redundant work and potential inconsistencies if something is missed.

Translations
Leaflet updates must be applied across all language versions, which introduces significant complexity. When changes are made—especially after content reuse—they often trigger new translation requirements. These translation cycles can be just as time-consuming as the original update process and are equally prone to user error, if not more so.

The Leaflet Automation Answer

The Esko automation vision is built on speed, quality, and compliance.

During the webinar, our experts showcased how a comprehensive approach simplifies and optimizes leaflet creation from start to finish.

Missed it? Let’s recap what they shared.

Content Management

Esko WebCenter offers content management capabilities, allowing teams to break content into reusable chunks, manage translations, and centralize metadata.

This is foundational for consistent, scalable leaflet production.

InDesign Previewer

Through integration with InDesign Server, WebCenter provides real-time previews of leaflets.

This enables teams to apply content, edit layouts, and visually validate output within a browser-based environment without needing a dedicated designer.

Rules Engine for Regulatory Compliance

The WebCenter Tasks Plugin offers powerful layout intelligence, including:

  • Automating font sizing, paragraph styling, and spacing.
  • Dynamically applying language-specific rules (i.e. for Japanese, Hebrew, Arabic, etc.).
  • Supporting color changes based on dosage or regulatory requirements (i.e., making all headings red for a specific region).

AI-Powered Content Mapping

AI-driven content mapping, currently in development, will allow WebCenter to ingest Microsoft Word documents and automatically extract content into structured XML formats. This capability will be guided by predefined rulebooks based on EUPI, PPI, and other health authority standards.

This eliminates enormous manual effort in transitioning all product leaflets to structured content and automation.

The result is a flexible framework where content, styling, and templates are separated, allowing for fast updates, scalable output, and full regulatory traceability.

It’s the holy grail of leaflet automation.

The e-Leaflets/ePILs Transition

The industry is rapidly moving toward digital formats for IFUs.

According to webinar polls, while 50% of participants already use electronic PDF leaflets in some markets, 40% still rely on physical IFUs, and only 7% have adopted interactive web-based formats like videos or webpages.

While the shift has begun, the criteria for adoption are still being defined and most country Health Authorities continue to require physical IFUs. Nonetheless, it is likely that future participants will seek out solutions including capabilities that allow:

  • Easy transition from structured content to PDFs, websites, or video scripts.
  • Centralized control over both print and digital outputs, ensuring consistency across all formats.
  • Future expansion to interactive and animated experiences that align with modern user expectations and global accessibility requirements.

Reaching into the Future

By bringing automation and AI into the leaflet creation process, life sciences companies can move from manual processes to an efficient, automated future—one where leaflets are compliant by design and ready in days, not months.

Are you ready to take the first step? Learn more about Automated Artwork today.

About the Author

Alexandra Blanck, a member of the Esko Corporate Marketing team, is known for her dedication to crafting engaging content that resonates with global audiences. As a Content Manager, she brings a strong editorial perspective and strategic insight to Esko’s communications, with a passion for turning complex topics into compelling narratives. Beyond her work at Esko, Alexandra is known for her creativity and storytelling expertise with a diverse writing portfolio that spans lifestyle features, fiction, and poetry.

Alexandra Blanck