In an industry as tightly regulated and globally interconnected as pharmaceuticals, labeling is far more than a back-office function; it’s a core business process. Done well, it enables speed to market, ensures compliance, and protects patients. Done poorly, it opens the door to costly recalls, regulatory fines, and reputational damage.
As we look to the second half of 2025, pharma businesses face a convergence of pressures: evolving global regulations, increasingly complex supply chains, rising demand for faster product launches, and the need for more agile digital systems. And at the center of all of these challenges? Labeling.
Here are the five critical labeling challenges pharma companies must address in 2025 and what a forward-thinking strategy looks like.
1. Disconnected Systems That Stifle Agility
Many pharma companies still manage labeling using fragmented systems: separate tools for artwork creation, review, translation, and approval, often spread across multiple global teams. This creates gaps in data flow, increases the risk of miscommunication, and makes traceability difficult.
A 2023 report from IDC found that over 60% of life sciences organizations cite “lack of integration across systems” as a top barrier to digital transformation efforts in regulatory and labeling processes.
The fix:
Integrated labeling platforms that connect directly with ERP, PLM, and regulatory systems allow labeling to evolve from a siloed process to a strategic asset. When data flows freely across functions, businesses gain speed, consistency, and control.
2. Regulatory Overload Is Reaching a Tipping Point
Compliance demands are only growing. From FDA and EMA expectations to country-specific serialization, language, and medical device regulations like EU MDR and the U.S. Drug Supply Chain Security Act (DSCSA), pharma businesses must now manage more requirements than ever, across more products and regions.
According to Deloitte, regulatory complexity has doubled in the past decade, and it continues to increase year over year.
The fix:
Digital labeling solutions that offer built-in version control, audit trails, and electronic approvals can dramatically reduce the risk of non-compliance. They also help ensure that any changes driven by regulation or internal updates are captured and deployed globally with confidence.
3. Manual Review Processes Create Bottlenecks
In many organizations, reviewing and approving label content is still a manual, time-intensive process involving emails, PDFs, and offline markups. This slows down product launches and creates room for human error.
McKinsey estimates that manual processes account for up to 40% of delays in product labeling, especially in organizations lacking standardized workflows.
The fix:
Automated comparison tools, digital annotations, and workflow-driven approvals can cut label review times from hours to minutes, without compromising quality or compliance.
4. Global Complexity Adds Localization Pressure
Launching a product globally means managing dozens of local label variations — from language translations to regulatory disclaimers and packaging layouts. When done manually, this slows down launches and increases the risk of inconsistencies.
An Accenture study found that pharma companies managing localized label content manually can spend 25-30% more time per product launch compared to those using centralized systems.
The fix:
Modern labeling systems that support dynamic content management, built-in language libraries, and market-specific templates can accelerate localization, ensuring global consistency without sacrificing regional compliance.
5. Siloed Teams and Suppliers Limit Visibility and Control
Labeling often spans departments, from regulatory and marketing to external vendors and packaging suppliers. Without a unified system and clear role-based access, companies risk losing oversight and control over critical updates.
According to the FDA, over 50% of drug recalls in the last five years were related to labeling issues, many tied to coordination breakdowns during product or market changes.
The fix:
A centralized labeling environment with configurable access controls allows cross-functional teams and external partners to collaborate in real time, with clear audit trails, user accountability, and full visibility at every stage.
The Bottom Line
Labeling is no longer a static, back-office function. It’s a dynamic, strategic capability that touches every part of a pharmaceutical business, from regulatory affairs and supply chain to patient safety.
In 2025, the pharmaceutical companies that win will be those that treat labeling not as a necessary burden, but as a competitive advantage. By investing in integrated, digital-first solutions that solve these five challenges, organizations can achieve faster time to market, ensure global compliance, and minimize the risk of costly disruptions.
If you’re ready to explore what a future-ready labeling process could look like, book a demo with our team today and see how Veraciti™ can transform your labeling and artwork management. Alternatively, speak to one of our experts on +44 (0) 1827 318100 or enquiries@kallik.com.