Struggling with labeling complexity in pharma?

You’re not alone. Pharmaceutical and life sciences companies face mounting pressure to meet global regulatory demands, maintain 100% labeling accuracy, and accelerate product launches — all while managing siloed systems and complex stakeholder workflows. Errors aren’t just costly — they’re dangerous. This white paper explores the real risks, challenges, and hidden inefficiencies that stem from outdated Labeling and Artwork Management (LAM) practices.

Discover how Kallik Veraciti transforms labeling for regulated industries

Purpose-built for pharma and medical device manufacturers, Veraciti is a cloud-native platform that centralizes label content, automates artwork generation, and ensures compliance with standards like FDA 21 CFR Part 11 and EU MDR. This paper shows how Kallik’s content-first, AI-enabled approach reduces errors, improves speed-to-market, and offers a true competitive advantage — with a side-by-side comparison against other major LAM solutions.
 

View the white paper

Medical device manufacturers are required to provide clear, accurate, and up-to-date instructions for use (IFUs) to ensure patient safety and regulatory compliance. Traditionally these instructions have been provided in printed format, but as digital solutions become more practical and widely accepted, many manufacturers are transitioning to electronic instructions for use (eIFUs).

Adopting eIFUs can improve accessibility, reduce costs and is better for sustainability. However, it also introduces new compliance challenges and considerations. This guide explores eIFU regulations, benefits, challenges, and best practices for implementation, as well as how software can help manufacturers manage compliance efficiently.

What is an eIFU?

An electronic instruction for use (eIFU) is a digital version of the traditional printed IFU. Instead of being included in product packaging, eIFUs are made available through a secure website, QR code, or other digital formats.

The transition to eIFUs is being driven by regulatory updates, advancements in technology, and industry-wide efforts to reduce costs and environmental impact. Electronic IFUs enable real-time updates, ensuring that healthcare professionals, and consumers, always have access to the most accurate and up-to-date instructions.

Why transition to eIFU? 

While traditional paper IFUs have long been the standard, and are still required for some devices, advancements in technology and evolving regulatory changes have made digital alternatives more practical, sustainable and beneficial.

For manufacturers, healthcare professionals, and regulatory bodies alike, eIFUs offer several key advantages:
 

“With so much change afoot in the industry, from regulations and policies, it’s no surprise that more and more medical device manufacturers are moving towards digital labeling and packaging. Traditional IFUs no longer meet the requirements, nor the increasing demand the industry continues to see.

With the right technology at their fingertips, eIFUs now take just minutes to update. Key information, across multiple products and markets, can be at the fingertips of medical professionals and, crucially, consumers, in an instant.

Critical to the future of the industry, the introduction of eIFUs will help to improve efficiencies, reduce error rate, remove additional burden from already time-pressed healthcare professionals and drive sustainable practices, all while ensuring the safety of patients. EIFUs are a welcome solution to the fast-paced medical device industry.” - Stuart Powell, Chief Product Officer at Kallik

What regulations apply to eIFU?

Medical device manufacturers looking to implement electronic instructions for use (eIFUs) must comply with strict regulatory requirements to ensure accessibility, accuracy, and patient safety. 

EU Regulations: MDR & Implementing Regulation 2021/2226

The European Union has established Regulation (EU) 2021/2226, which defines the conditions under which medical devices may provide eIFUs instead of printed documentation. This regulation applies to specific categories of devices, particularly those intended for professional use.

Key Requirements for eIFUs in the EU:

• eIFUs must be made available via a secure, compliant website that is regularly updated.
• The manufacturer must conduct a risk assessment to ensure that providing an eIFU instead of a printed IFU does not pose safety concerns.
• Printed IFUs must still be available upon request, and users must be informed of how to obtain them.
• The eIFU must be accessible in all official EU languages required for the device’s intended market.
• The eIFU must be designed to remain accessible for the expected lifetime of the device, even if the device is discontinued.
• Adequate cybersecurity measures must be in place to prevent unauthorized modifications to the eIFU content.

U.S. Regulations: FDA Guidance on eIFUs

In the United States, the FDA has comparatively less specific guidance on the use of electronic IFUs. However, they do permit eIFUs for certain prescription medical devices used in professional healthcare settings. This is outlined in Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) which states:

“Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.”

Key FDA eIFU compliance considerations:

• The eIFU must be accessible at the point of use and must not compromise device safety.
• The manufacturer must provide clear instructions on how users can access the eIFU.
• A printed version must be available upon request.
• The eIFU must be hosted securely to prevent tampering.
• Updates to the eIFU must be tracked and documented, ensuring that healthcare professionals always access the latest version.
• While the FDA has not yet mandated universal eIFU adoption, manufacturers considering digital IFUs should ensure they meet both FDA labeling regulations and Good Manufacturing Practices (GMPs).

How labeling management software can help

Managing electronic instructions for use (eIFUs) in compliance with regulatory requirements can be complex, especially for medical device manufacturers operating in multiple markets. Strict version control, multilingual requirements, real-time updates, and cybersecurity concerns make manual processes inefficient and prone to errors.

Labeling management software provides a structured, automated approach to eIFU compliance, streamlining workflows and reducing regulatory risks.

Kallik's end-to-end labeling and artwork management software helps medical device manufacturers to overcome challenges related to eIFU:

Automating compliance with regulatory standards:

• Comprehensive approval processes are required before publishing updates.
• Maintain audit-ready documentation for regulatory inspections.

Version control and change management:

• Automated version tracking, preventing outdated instructions from being accessed.
• Full audit trails, documenting changes, approvals, and user access.
• Role-based access control, ensuring only authorized users can edit or approve eIFU updates.

Centralized multilingual management:

• Ensure all language versions are consistent and compliant with local regulations.
• Updates can be efficiently applied across multiple languages without duplicating efforts.
• Translations can then be approved for accuracy, reducing the risk of misinterpretation.

Reducing manual work and human errors:

• Easily search for and replace specific symbols with automated ‘Where Used’ function
• Automate approval workflows, reducing delays in publishing updated IFUs.

Want to see how Kallik’s innovative software can benefit your labeling and artwork management process with the power of automation and AI? Get in touch by emailing enquiries@kallik.com or calling +44 (0) 1827 318100, or alternatively, book your one-to-one demo here. 
 

Last week, the team at Kallik had the privilege of attending the Gartner Supply Chain Symposium/XPO, the event of the year for supply chain professionals. The event was a fantastic opportunity to discuss the latest trends and hot topics while also exploring the most pressing issues in the industry. 

Supply Chain Hot Topics 

Across keynotes and sessions, a few clear themes stood out. In marketing, AI was the hot topic. It’s no longer just about using ChatGPT to write social posts. AI is already playing a major role in improving customer experiences and helping teams get more from their campaigns. But while the tech is advancing fast, there’s still a big need to understand the human side. Gartner pointed out how consumers are responding to AI in marketing and how CMOs need to balance the needs of real people with increasingly independent “non-human” audiences too.

On the supply chain side, resilience and agility remain front and center. Growth is still a key goal, and many companies are looking to expand into new markets using smart tech to help them get there. But there’s a challenge: talent. Finding the right digital skills is proving to be a real roadblock to full digital transformation. Add to that Gen Z’s demand for fast, seamless digital experiences, and it’s clear that supply chains need to keep evolving.
When it comes to technology, the spotlight was on connectivity and intelligence. Concepts like the “Augmented Connected Workforce,” “Polyfunctional Robots,” and “Agentic AI” point toward a future where smart, connected systems help teams work more efficiently and seamlessly. But Gartner also stressed that the right approach is key, as without a clear strategy, even the best tech can fall flat.

So What Does This Mean for Labeling and Artwork?

Just as AI is revolutionizing marketing and supply chains, it is poised to transform how we manage labeling and artwork. And as a vital part of the supply chain, it’s crucial that your labeling and artwork process is in the best possible shape. Imagine AI-powered tools that can predict potential compliance issues, automate the generation of variations based on regional regulations, and even assist in the creation of accessible and consumer-friendly label designs. The "Agentic AI" concept could translate to intelligent systems that proactively manage the artwork lifecycle, flagging potential bottlenecks and ensuring timely approvals.

The focus on data and analytics for improved performance, seen across marketing and supply chain discussions, is directly applicable to labeling. Robust artwork management platforms that provide comprehensive audit trails, version control, and real-time insights into the labeling process are becoming essential for ensuring compliance and building supply chain transparency. This aligns with the need for greater visibility to navigate market uncertainty.
 

Meeting the Demands of the Digital Native: Gen Z's preference for seamless digital experiences and self-service extends to product information. Clear, accurate, and readily accessible labeling information, often delivered digitally, will be crucial for engaging this demographic. Artwork management systems need to facilitate the creation and distribution of digital label content across various touchpoints.

The Need for Digital Dexterity in Labeling Teams: The talent challenges identified by Gartner in the broader supply chain landscape are also relevant to labeling and artwork management. As the industry embraces more sophisticated digital tools and AI-powered solutions, professionals in this space will need to develop new skills and embrace a culture of continuous learning.

Discussing AI with Kenvue’s Director of Digital Acceleration

It was against this backdrop of evolving technologies and shifting priorities that Kallik, in partnership with Kenvue, hosted our session: "Driving Supply Chain Results via AI Artwork Management and Labeling: The Kenvue Story." 

Gurdip Singh, CEO of Kallik, set the stage by highlighting the often-underestimated complexity of labeling, stating, "I came and joined the industry, and I was shocked to hear how many manual processes operate, how many mistakes are made. And it's something that I think is really critical for leaders like yourselves to fully embrace in terms of how much value can really be derived from that." 

Joe Konopka, Director of Digital Acceleration at Kenvue, then shared a real-world example of how the leading consumer health company is leveraging best-in-class tools and artificial intelligence to transform its artwork management and labeling processes. The session saw Konopka highlight how Kenvue transformed its labeling and artwork process from a fragmented, manual, and error-prone system into a streamlined, end-to-end digital ecosystem. Facing challenges during their split from Johnson & Johnson, they created a bold vision focused not just on replacing systems, but on accelerating innovation, improving compliance, and reducing rework through digitization. 

And the results speak for themselves. In one case, they were able to make packaging changes 95% faster — just by reusing existing content: "Now, it’s as simple as copy-paste." More than just speed, the transformation helped change mindsets. Konopka explained, "And so we started to ask, 'well, what if it wasn't that way?' 'Could you make more changes?' 'Could we be more dynamic?' 'Could we be more agile?'"

By building a structured content library and integrating AI to automate data handling—from ingredient updates to Amazon listings—they enabled content reuse, quicker label changes, and improved consistency across markets. Crucially, they emphasized change management, taking a phased approach that won internal buy-in and shifted organizational mindsets toward data quality and digital-first thinking.

Singh concluded the session by urging attendees to reconsider their perception of labeling, stating, "My last message to everyone here is, do think about labeling very differently to it just being a back-end process that underpins the business. It's an absolutely invaluable asset to accelerate your business."

You can watch the full session here to find out more about Kenvue’s digital transformation and its benefits.

Want to Know More?

Overall, the Gartner Supply Chain Symposium/XPO was a great opportunity to have meaningful discussions with some of the world’s leading supply chain professionals. For those of us in labeling and artwork management, it’s clear that AI, smarter data use, changing consumer expectations, and the growing demand for digital skills aren’t just buzzwords—they’re real drivers of change. 
 

Here at Kallik, our experts are here to help businesses stay ahead of the curve, building labeling and artwork processes that are agile, compliant, and future-ready. Our session with Kenvue was a great example of what’s possible when the right technology meets a bold vision. Want to see how we can help you stay ahead of the change? Get in touch with us today by emailing enquiries@kallik.com or calling +44 (0) 1827 318100. Alternatively, click here to book a demo and see what our software can do for your business.

It’s no secret that the importance of supply chain traceability and transparency is increasing constantly, so much so that it’s becoming a business imperative for staying competitive. From ensuring compliance to managing recalls, companies need end-to-end visibility over every component of their operations. Yet, one area often overlooked is the artwork approval process.

Labeling errors or untraceable changes to packaging artwork can have serious consequences—misidentification of products, compliance breaches, and costly delays, not to mention the reputational damage and risk to lives. That's why more companies are recognizing that traceability starts with approval workflows.

At Kallik, we understand the importance of traceability and the need to close the visibility gap in labeling and artwork management, which is why we’re here to change the game!

Why Artwork Approvals Matter for Supply Chain Traceability

Before a product reaches the shelves, its label passes through multiple departments, each with their own requirements. Without a centralized system, these workflows become fragmented, undocumented, and difficult to trace. This creates blind spots that compromise supply chain integrity.

But you can eliminate this risk by bringing every step of the artwork approval process into a single, configurable workflow, ensuring full visibility and accountability across all stakeholders.
 

The Importance of a Label Audit Trail

Our partners at TEKLYNX emphasize the significance of maintaining a detailed label audit trail. In their blog post, they state: "A label audit trail is a reliable, consistent way of documenting changes made to label designs. Maintaining an accurate label audit trail reduces the risk of labeling errors and helps pinpoint the cause if they happen."

They further highlight that labeling mistakes are no small issue, noting that at least 40% of recalls published by the United States Food and Drug Administration (FDA) are due to labeling errors.

By implementing a cloud-based, end-to-end solution, you can ensure that every change is documented, every approval is tracked, and every label is accurate—thereby enhancing traceability and reducing the risk of costly errors.

How to Achieve End-to-End Visibility

Kallik’s end-to-end, cloud-based software, Veraciti, was designed with highly regulated industries in mind. Veraciti gives you complete control over the artwork approval process, with configurable workflows that reflect your internal structure—whether that’s a simple sign-off or a multi-stage route through marketing, legal, and regulatory. You can assign specific approvers at each step, and the system logs every action for full traceability. What’s key, is that it’s your choice! It can be completely adapted to meet the needs of your business.

Artwork can be reviewed directly in-platform, with tools for commenting, annotating, and highlighting specific layers or colours. These updates appear live, so multiple reviewers can collaborate simultaneously. All feedback is captured in an audit trail that’s locked down for integrity—while you can remove your own comments (with a required reason), other users' input is protected and cannot be altered, ensuring nothing slips through or is lost.

Built-in inspection tools highlight any changes between versions side by side, making it easy to review updates. And with the option of ‘pixel to pixel’ to compare visual assets at the pixel level, ideal for spotting graphical changes, or ‘text to text’ for detecting any variation in written content, its easier than ever to keep reviews error-free.

In addition, users must provide reasons for any rejections or changes, creating a clear record of decisions. You can also link order numbers to labels to ensure the right content is used for each product run.

Once approved, artwork is stored in the Asset Manager and made available for print at selected factories. Start dates can be scheduled, and outdated versions are automatically archived to avoid production errors.

Finally, Veraciti’s reporting dashboard gives you oversight across your entire process—showing approval times, identifying bottlenecks, and tracking project statuses to help you continuously improve.

No More Guesswork—Just Proof

By embedding traceability into the artwork approval process, Veraciti ensures that the right version of the right label gets to the right product, every time. Whether you're managing complex regulatory artwork for pharmaceuticals or multi-language packaging in consumer goods, Veraciti gives you the control and transparency needed for today's supply chains.

Want to see how Veraciti can make your labeling and approvals traceable from start to finish? You can read our free guide, A Supply Chain Director’s Guide to Labeling in 2025, for expert advice on how to future-proof supply chains with digital labeling and automation for end-to-end traceability. Alternatively, click here to book a demo or speak to one of our friendly experts by emailing enquiries@kallik.com or calling +44 (0) 1827 318100.

Even a small change to a labeling symbol can ripple across global operations, causing serious delays and risking costly recalls. With the newly announced shift from “EC REP” to “EU REP” as outlined in the latest amendment to ISO 15223-1, it’s important to get started on implementing mass changes as soon as possible to maintain compliance and prevent reputational damage. So, what does this latest regulation update mean for your business, and how can you stay ahead?

What’s Changing with ISO 15223-1?

The ISO 15223-1:2021+Amd 1:2024 standard introduces a key update: the traditional "EC REP" symbol used to indicate an authorised representative in the European Community is being phased out in favour of a more regionally adaptable “XX-REP” format.

For manufacturers selling into Europe, this means adopting the “EU REP” symbol to represent their European Union Authorised Representative. Other variations like “CH REP” (Switzerland) and “UK REP” (United Kingdom) are also emerging in local jurisdictions.

This change reflects today’s political borders and helps create a more adaptable approach to labeling in different regions as well as eliminating any confusion with the symbols. You can read more about the update here.

Why It Matters

While this may seem like a minor design tweak, the impact is significant—especially for manufacturers operating across the world. With every single use of the “EC REP” symbol needing to be identified, replaced and re-approved, companies often turn to expensive third parties to make these changes. With proper end-to-end labeling and artwork management software that can automate these changes, the process can be quick, simple and smooth, all while keeping costs down.

Beth Peckover, Chief Delivery Officer at Kallik explains: “While comprehensive labeling software may seem like a significant upfront investment, the ability to instantly implement thousands of updates in response to evolving regulations can save businesses enormous time, cost, and compliance risk in the long run. Regulations are constantly changing–and fast–meaning automation isn’t just a nice-to-have, it’s essential for staying competitive and audit-ready.”

How Kallik Can Help

At Kallik, we help medical device and pharmaceutical companies stay ahead of regulatory changes with powerful automation. With Veraciti™, you can update 10,000 labels in just 14 days—compared to six months using traditional methods—thanks to our smart, automated approach.

Our ‘Where Used’ function instantly identifies where a specific symbol or warning appears across all artworks and labels, enabling fast, accurate updates. Veraciti also flags layout issues, handles size variations across product ranges, and ensures changes don’t compromise compliance.

By replacing manual processes with cloud-based automation, customers have seen up to a 70% reduction in artwork costs. Tools like Automated Artwork Generation and Cascade maintain brand consistency and allow seamless integration with design tools like Adobe InDesign. Veraciti even automates approval workflows, cutting delays and accelerating time to market.

Future-Proofing Your Labeling Strategy

The update to ISO 15223-1 isn’t an isolated change—it’s part of a broader trend toward greater localization and increasing regulatory divergence across global markets. The emergence of country-specific reps and corresponding symbols (EU REP, UK REP, CH REP, NZ REP) only adds to the complexity.

This makes it more important than ever to modernize your labeling systems. Manual processes and fragmented artwork files simply won’t scale in a world where regulatory updates can happen any time, anywhere. With Kallik, your business is ready not just for today’s changes, but for whatever comes next.

Ready to Simplify Your Labeling Compliance

Whether you're preparing to update your EU REP symbol or facing broader challenges with global labeling requirements, Kallik can help. Speak to one of our labeling and artwork experts to learn more about how Veraciti™ can help your business thrive in a rapidly changing regulatory environment. Get in touch today at enquiries@kallik.com or call +44 (0) 1827 318100.

Counterfeiting, product recalls, and supply chain disruptions are on the rise, meaning regulatory compliance is a non-negotiable for pharmaceutical companies. At the heart of that compliance sits one critical component: labeling. And when it comes to regulations like the U.S. Drug Supply Chain Security Act (DSCSA), the quality and accuracy of your labeling and artwork management processes could mean the difference between smooth operations and costly non-compliance.

What Is the DSCSA?

The Drug Supply Chain Security Act (DSCSA) is a U.S. federal law introduced in 2013 that aims to protect consumers from counterfeit, contaminated, or otherwise unsafe drugs. Its ultimate goal? To create an electronic, interoperable system that can trace prescription drugs throughout the entire supply chain.

Here’s what DSCSA requires in a nutshell:

• Every package and case of prescription drugs must carry a unique identifier
• Companies must be able to track and trace every unit across the supply chain at the unit-level
• Businesses need to verify the product’s legitimacy before it’s sold or returned
• Information about products must be shared digitally between supply chain partners

This regulation affects every player in the pharma supply chain—manufacturers, repackagers, distributors, and dispensers. And while much of the attention has focused on serialization and data exchange, one essential component is often overlooked: the role of labeling and artwork management in achieving DSCSA compliance.

Why Labeling Matters Under DSCSA

A label isn’t just a regulatory box to tick, it’s the vehicle for the serialized data that DSCSA requires and a critical touchpoint for verifying authenticity and ensuring supply chain continuity.

If your labels are:

• Inconsistent across products or facilities
• Incorrect due to manual entry
• Not linked to an audit trail
• Unable to adapt quickly to new regulations

…then you’re putting your business at serious risk.

What’s more, if you're still managing labeling processes manually or across disconnected systems, the chances of non-compliance skyrocket. Errors in serialization, mislabeling, or delays in label changes can lead to serious consequences, from major delays in getting products to market to recalls and fines, and not to mention the serious risk to consumers.

Why 2025 Is the Turning Point

With the DSCSA enforcement deadline now in full effect, 2025 is the year organizations will either succeed or stumble depending on their labeling and artwork process. And that’s not just about DSCSA. It’s about the future of supply chain compliance. The growing complexity of global regulations, such as the EU MDR, UKCA marking, and ESG reporting, means pharma companies must adopt a future-proof labeling strategy. Relying on manual methods or fragmented platforms simply doesn't cut it anymore.

The Solution: Digitization

Digitizing your labeling and artwork management process is a game-changer for compliance. A centralized, cloud-based platform like Kallik’s Veraciti™ empowers organizations to create and manage labeling and artwork with complete consistency and accuracy across the globe. By replacing manual processes with AI and automation tools, businesses can significantly reduce the risk of errors while increasing efficiency and, therefore, speed-to-market. Plus, every action and change is tracked in a full audit trail, giving companies the traceability they need to meet strict pharmaceutical regulations with confidence. With Veraciti, labeling is no longer a stressful, monotonous task, but a powerful tool for driving transparency, accountability, and operational efficiency across the entire supply chain.
 

Understanding the Future of Supply Chains: Download the New Guide

If your organization is struggling with compliance, our experts are ready to help. Our new guide, “A Supply Chain Director’s Guide to Labeling in 2025,” explores how to future-proof your supply chain with AI, automation, blockchain, and other technologies that go far beyond DSCSA.

Download the guide today to learn how you can:

• Eliminate compliance risks with smarter labeling
• Improve traceability across multi-region supply chains
• Reduce costs, errors, and time-to-market

Don’t let outdated labeling processes hold you back from DSCSA compliance. The future of pharmaceutical supply chains depends on transparency, accuracy, and agility, and it all starts with your labels. Want to know more about digitizing your labeling process? Speak to one of our experts on +44 (0) 1827 318100, email enquiries@kallik.com or click here to book a demo.

In our Meet the Expert series, we shine a light on the people behind the technology – the experts driving innovation, transformation, and customer success at Kallik. This week, we sat down with Sharad Khusal, our Senior Vice President Sales – Americas, to talk about what drew him to the labeling and artwork industry, what trends he sees on the horizon, and what inspires him both inside and outside of work.

Sharad’s Introduction to Labeling and Artwork Management

In my previous role as the head of the Global Life Sciences business at DXC Technology, I had the opportunity to work closely with a range of partners and explore their solutions. That’s when I was introduced to Kallik. Their approach to labeling and artwork management really stood out, especially in how they were digitally transforming a space that hadn’t seen much innovation at the time.

What impressed me even more than the technology was the leadership team. Their collaborative mindset and commitment to solving truly complex challenges in the pharma and medical device industries resonated with me. So, when Kallik approached me about joining their team to support growth in the Americas, it felt like a natural next step. I was excited to be part of a company with such a forward-thinking vision and potential to make a real impact.

I’ve been involved in the labeling and artwork industry for over a decade, particularly in the context of life sciences. Throughout my career, I’ve built expertise in regulatory compliance, document control, submission management, and broader supply chain support – all within highly regulated environments like pharma and medical devices.

These experiences have helped me understand what businesses in this space truly need – whether it’s navigating compliance, accelerating speed-to-market, or creating more scalable and efficient processes. I bring that insight to the table to help customers overcome roadblocks and future-proof their operations.

The Challenges and Rewards of the Job

The job definitely isn’t without its challenges. A few years ago, I was managing a key account for a global pharmaceutical distributor in the U.S. We were gearing up for a major executive presentation, but the project was off-track and missing key milestones. I was brought in to assess and turn it around.

I quickly realized that the core issue wasn’t technical; it was down to collaboration and communication issues. As a result, I stepped in to take over the role, reset team expectations, and re-establish a collaborative environment.

We realigned on goals, clarified roles, and rebuilt trust, not just within the team, but with the client too. By focusing on open communication and unity, we delivered the final presentation on time. That experience reinforced for me how vital leadership and collaboration are in driving outcomes.

Despite the challenges that arise sometimes, it’s an extremely rewarding role thanks to the relationships. For me, I enjoy building strong, trust-based relationships with our customers. Throughout my career, I’ve always been in customer-facing roles, and I’m driven by helping clients solve real challenges, making their day-to-day work easier, more efficient, and more successful.

The most satisfying moments are when clients reach out to me for guidance on matters beyond the immediate scope of my role. That level of trust, when they see me not just as a vendor but as a strategic advisor, means I’ve earned a place as a true partner in their success. That’s what I strive for every day.

Staying Ahead of Industry Trends

The pace of change in our industry is only accelerating, especially across regulated sectors. Some of the major trends I see include:

Regulatory complexity: Global regulations like FDA, EMA, MDR, and UDI are evolving fast, and businesses need agile, audit-ready processes to keep up.

• Digital transformation & automation: Companies are moving away from manual processes and embracing cloud-based, AI-driven platforms to boost efficiency and reduce risk.
• Sustainability: ESG goals are pushing for eco-friendly labeling practices, like waste reduction and digital traceability.
• Globalization: Businesses need scalable solutions that work consistently across regions and can adapt quickly to supply chain shifts.
• On-demand, personalized labeling: Advances in digital printing are making real-time, market-specific labeling essential.

At Kallik, we’re staying ahead of these shifts by investing in cloud-native technology, AI, and automation. Our platform helps customers stay compliant, streamline operations, and reduce waste – all while scaling globally and adapting to what’s next.

What Sets Kallik Apart

Labeling is often overlooked, simply considered a downstream task–something to handle at the end of the product journey. But here at Kallik, we know that couldn’t be further from the truth! At Kallik, we know labeling is a critical control point that affects compliance, time-to-market, and even patient safety. At Kallik, we help organizations turn labeling from an operational risk into a strategic advantage.

In my view, what really sets Kallik apart is our ability to offer a true end-to-end solution that covers the entire labeling and artwork process in one unified platform, eliminating the need for multiple tools or applications. We also lead the way in composability, providing a level of modular, flexible configuration that even Gartner has recognized. Our AI-powered onboarding tool accelerates migration significantly, while our Where Used functionality enables customers to make bulk changes at scale, quickly and consistently. And as a cloud-native platform from day one, we bring over 20 years of cloud expertise—something most competitors are only just beginning to build.

What advice would you give to businesses looking to improve their labeling and artwork processes?

My biggest piece of advice is to look beyond isolated features. You need to think holistically: what will truly improve efficiency, scalability, and compliance over the long term? I’d also suggest choosing a vendor with proven cloud experience, strong security credentials, and an integrated platform that unites collaboration, content management, and compliance in one place. A piecemeal approach just won’t cut it in today’s regulated markets. That’s why I believe Kallik is the best choice, as we don’t just help global businesses fix their labeling challenges, but also evolve their processes for the future.

Sharad Outside of Kallik

Outside of work, I enjoy listening to music, watching films, and taking long walks in the park – all great ways to reflect and reset. I also love spending time with my son, especially when we go go-kart racing or play pool together. It’s a fun way to stay active and connected.

One thing that might surprise people is that I used to be a goalkeeper on my high school soccer team – and I still enjoy playing and watching soccer today.

What Inspires Sharad?

Some things that have always stuck with me are from my father and teachers: “Never give up” and “Keep on striving.” Simple, but powerful. Another one I live by is the idea of “living a rich life now and a richer life in the future.” It’s about embracing growth and resilience and always aiming higher, both personally and professionally.

If I could have dinner with any celebrities, they’d be Mahatma Gandhi and Nelson Mandela. Their stories of resilience, patience, and nonviolent leadership are incredibly powerful. They didn’t just lead; they lived their values, even when the stakes were immense. During one of the most demanding periods of my life – working full time, travelling constantly, and pursuing an MBA – I found strength in their journeys. Their commitment to positive change continues to inspire me every day.

Speak to Sharad About Your Label and Artwork Process

Looking to improve your labeling and artwork management process? Why not chat to Sharad? Contact our experts by clicking here, emailing enquiries@kallik.com, or calling +44 (0) 1827 318100.
 

The pace of technological advancement continues to reshape industries, and labeling and artwork management is no exception. As businesses strive to enhance efficiency, ensure compliance, and futureproof their operations, staying ahead of emerging trends is crucial.

A newly released report from Gartner highlights the top industry trends shaping supply chain packaging strategies in 2025 and beyond. In this blog, we explore the key takeaways from the report and share how businesses can stay ahead of these trends and futureproof their operations.

Key Trends from the Report

1. Digital Transformation: AI and Automation

Unsurprisingly, the report underscores the increasing adoption of AI and automation to streamline complex workflows, reduce human error, and drive greater efficiency. In labeling and artwork management, AI plays a pivotal role in automating regulatory compliance, content validation, and approval workflows. AI tools can even analyze data and predict packaging decisions, allowing for more tailored and successful product launches.

As stated in the report, "By 2028, the label and artwork management market will be dominated by a small handful of vendors who have mastered cloud, machine learning and AI capabilities." Organizations that don’t evolve risk being left behind by more agile, tech-enabled competitors.

This transformation is about more than just keeping pace. The report also emphasizes the tangible returns: "Technologies and software suites in the LAM (labeling and artwork management) market have rapidly advanced, enabling system upgrades to avoid issues related to labeling and artwork errors. These systems also enable a robust ROI once fully implemented."

The message is clear: embracing AI-driven automation isn’t just a smart move, it’s a non-negotiable for staying relevant, compliant, and competitive. Now is the time to invest in future-ready systems that will define the next era of labeling and artwork management.

To understand more about the importance of the digitization of labeling and artwork processes, you can read our recent blog on the topic here.

2. Cloud-Based Solutions & Enhanced Collaboration

As mentioned above, cloud-based solutions are also a key part of embracing technology in the labeling and artwork management process. The rise of remote work and global collaboration has accelerated the adoption of cloud-based solutions. The report highlights the importance of secure, scalable, and centralized platforms that allow teams to collaborate efficiently across multiple locations.

According to the report, "Many organizations find that they have multiple legacy LAM software solutions that are disconnected, or rely on outdated versions of software that limit access to current capabilities." This fragmentation stifles collaboration and increases risk.

To stay agile in a distributed, digital-first world, organizations must move beyond fragmented legacy systems. Cloud-based platforms not only enable real-time collaboration, they also reduce risk, improve control, and ensure everyone is working from a single source of truth. If communication breakdowns and collaboration gaps are leading to costly mistakes, cloud solutions offer a clear path forward, bringing teams, data, and processes together in one secure, scalable space.

If you’re still unsure whether a cloud-based solution is right for your business, check out our handy blog ‘Cloud-Based vs On-Premise Labeling Software: Choosing the Right Solution for Your Organization’.

3. Regulatory Complexity & Compliance Challenges

With global regulatory requirements changing constantly, organizations face growing challenges in maintaining compliance. The report highlights the need for adaptive solutions that can keep up with shifting regulations, particularly in highly regulated industries like pharmaceuticals, medical devices, and consumer goods. You can read more about how the right software is crucial to achieving 100% regulatory compliance here.

As the report rightly warns, "The financial risks of mislabeling products, artwork delays, market access delays and fines due to regulatory noncompliance are leading organizations to upgrade their label and artwork applications." Now more than ever, outdated labeling and artwork processes are putting compliance, market access, and brand reputation on the line. Ultimately, it’s crucial to ensure that your labeling and artwork management process is up to the job. To understand more, our recent blog, aimed at helping CFOs to understand more about the financial implications of getting it right (or wrong!) might be helpful.

4. Sustainability & Digital Labeling

Sustainability is no longer just a brand value—it’s a regulatory and operational imperative. The report highlights that “by 2025, 90% of public sustainable packaging commitments won’t be met” due to continued reliance on plastics and single-use formats. In response, major brands are resetting targets and extending timelines to 2030, acknowledging the technical and financial challenges involved.

At the same time, regulatory pressure is intensifying. New legislation, like extended producer responsibility (EPR) schemes and the EU’s Packaging and Packaging Waste Regulation (PPWR), is turning sustainability into a compliance requirement. Organizations must now provide detailed data on recyclability, material use, and waste reduction.

The report also points to waste reduction as a rising strategy, particularly in B2B sectors. Companies are cutting unnecessary packaging and exploring reusable systems, such as Microsoft’s server rack solution that’s reused up to 70 times and contains over 50% recycled content.

Digital labeling plays a vital role here. Formats like eIFUs and QR-code-based labels reduce paper usage and enable dynamic updates—lowering environmental impact while ensuring up-to-date compliance.

Futureproofing with Veraciti

The trends outlined in Gartner’s report reinforce the need for intelligent, scalable, and future-ready solutions. At Kallik, we understand the challenges of modern labeling and artwork management, and our Veraciti platform is designed to help businesses navigate these industry shifts with confidence.

By leveraging AI, automation and cloud-based collaboration, Veraciti enables organizations to enhance efficiency, reduce risk, and stay ahead in an ever-changing landscape. And if it’s the migration process putting you off making that switch, Kallik’s AToM (Assisted Technology of Migration) leverages cutting-edge AI to simplify and streamline the labeling and artwork migration process with machine learning. The days of lengthy, complicated onboarding processes are ove thanks to AToM, so now you can make the switch and be headache-free!

Ready to future-proof your business? Speak to an expert today!

By leveraging Gartner’s insights and adopting innovative solutions like Kallik’s Veraciti, organizations can streamline their workflows, enhance compliance, and achieve sustainability goals—all while staying ahead of the competition. You can find Gartner’s full guide here.

Looking for advice on how to improve your label and artwork process? Get in touch with a Kallik expert today by emailing enquiries@kallik.com or calling +44 (0) 1827 318100.
 

At Kallik, our success isn’t just driven by cutting-edge technology—it’s powered by the incredible expertise and dedication of our team. One of the key figures behind our mission to transform labeling and artwork management is Liam Conlin, VP of Sales Europe. With over 15 years of experience spanning packaging design, labeling, and artwork management, Liam brings a wealth of industry knowledge and a deep understanding of the challenges our clients face. His passion for driving positive change and helping clients navigate complex labeling environments makes him an invaluable leader at Kallik.

An Unexpected Journey into Labeling and Artwork

Liam’s entry into the world of labeling and artwork management came through a unique path. While working as an Account Director for The Watt Group, a Canadian artwork and packaging design agency, he was involved in a high-profile project when Walmart acquired Asda and wanted to rebrand its offerings in the UK and Germany. This experience introduced Liam to the intricacies of labeling and artwork processes, sparking a passion that would define much of his career.

With over 15 years in the industry, Liam has witnessed firsthand the dramatic evolution of labeling and artwork processes—from the days of physically drawn artwork to the digital transformation driven by AI and automation. Reflecting on this journey, Liam explains: “In my early days, we were still manually creating artwork, and then came the rise of Macs and digital tools. Now, with Kallik’s Veraciti, we’re using AI to migrate data, digitize artwork and labels, and automate thousands of change requests without any human involvement.”

His extensive experience across different roles and projects has given Liam a unique perspective, allowing him to empathize with clients navigating complex regulatory and operational challenges.

For Liam, the most rewarding aspect of his role is helping clients achieve meaningful business transformation. He recalls a particularly demanding project from a decade ago that left a lasting impression: “I coordinated a project for 1,000 SKUs to be changed due to EU directives. It was a manual nightmare—emailing PDFs for approval, chasing suppliers, legal teams, marketing departments, and printers, all while maintaining a massive spreadsheet. It turned my hair grey! So, when I see a client or prospect in that situation today, I truly empathize and feel genuinely relieved when I can solve those issues with our end-to-end Veraciti solution.”

Staying Ahead of Industry Trends

Liam has a keen eye on the evolving trends in the labeling and artwork industry, ensuring that Kallik stays ahead of the curve. He highlights three major shifts shaping the industry:

Cloud-Based Solutions: “The cloud has been around for years as the future, yet many competitors still operate 50/50 or 60/40 on-premise. Kallik has been 100% cloud-based since our inception in 2001, giving us a significant edge in flexibility, scalability, and security.”

AI and Automation: “We’re leading the market in leveraging AI for data migration of artwork and label files, along with automating artwork creation and change management. However, maintaining high levels of R&D is critical to staying ahead and meeting our clients’ evolving needs.”

The Rise of E-Labeling and QR Codes: “E-labeling and the increasing use of QR codes for environmental legislative compliance are becoming essential. Businesses need to prepare for this shift to remain compliant and competitive.”

What Sets Kallik Apart?

Liam believes that Kallik’s approach to labeling and artwork management is unique. Building on his earlier comments, he emphasizes: “At Kallik, we don’t just think about artwork and  labels as finished products. We deconstruct labels, digitizing them such that we do not look at artwork files or label templates in isolation but how their constituent assets; phrases, icons, logos etc are linked to and shared by other skus and templates, allowing for searchability, standardization, and automation of changes across tens of thousands of SKUs in a fraction of the time that it would take to brief X number of individual ‘human’ artworkers to make the changes. This means our Client Partners reduce costs and get their products on-shelf up to 70% faster than they did previously. No one else in the industry thinks like us, and that’s what makes Veraciti so unique.”

One misconception Liam is passionate about addressing is the underestimated importance of labeling in business operations. “Labeling plays a critical role in ensuring compliance, protecting consumers, and maintaining brand consistency. Look at Natasha’s Law—it’s a stark reminder of how vital accurate labeling is. Yet, I rarely encounter prospects with ‘labeling’ in their job titles. When I do, I know they’re on the right track because they recognize its importance.”

Liam’s advice for businesses looking to optimize their labeling and artwork processes is simple but powerful: “Understand that both key processes—artwork and labeling—can be managed under a single, end-to-end solution like Kallik’s Veraciti. Often, artwork sits with the marketing team, while labeling falls under IT or supply chain. My role is to help these separate disciplines realize they can work together to drive greater ROI with a unified solution.”

Liam Beyond the Office

When he’s not helping clients transform their labeling processes, Liam is an adventurer at heart. He’s a dedicated Munro bagger (climbing Scottish mountains over 1000 metres) and has conquered 90 out of the 282 Munros so far. He recalls one particularly nerve-wracking adventure: “I tackled the terrifying Munros in the Cuillins on Skye, using ropes with 1,000-meter sheer drops and gale-force winds. Definitely one of those ‘don’t look down’ moments!”

Liam is also an avid cyclist, having recently completed the Leeds-Liverpool canal on a mountain bike (though he wisely took the train back!). For a bit of balance, he enjoys meditation and weightlifting—though not at the same time, he jokes.

When we asked Liam about any mottos or quotes he lives by, he said he draws inspiration from a timeless quote by Robert Louis Stevenson: “Do not judge each day by the harvest you reap but by the seeds you plant.” This philosophy guides both his professional and personal life, emphasizing the importance of long-term impact and continuous growth.

If Liam could have dinner with anyone in the world, dead or alive, his dream guest list would include a mix of music, sport, humor, and literature: John Lennon, Muhammad Ali, Billy Connolly, and William Shakespeare. “It would tick all my boxes—music, sport, humor, and great literature. I’d love to hear their perspectives on life and their unique journeys,” Liam explains.

Liam Conlin’s deep expertise, passion for problem-solving, and commitment to staying ahead of industry trends make him a driving force at Kallik. Looking to improve your labeling and artwork management process? Why not chat to Liam? Contact us by clicking here, emailing enquiries@kallik.com, or calling +44 (0) 1827 318100.
 

The FDA has announced significant updates to the labeling requirements for testosterone products, set to take effect in 2025. These changes, aimed at enhancing patient safety and ensuring clearer communication of risks, will impact pharmaceutical manufacturers, distributors, and healthcare providers alike. As with any regulatory shift, staying ahead of compliance is key to avoiding costly delays and ensuring product availability. But what exactly do these new changes entail, and how can companies prepare to meet these new requirements effectively?

Understanding the New FDA Labeling Changes

On February 28, 2025, the FDA issued new guidelines requiring changes to the labeling of testosterone products, particularly focusing on:

Enhanced Risk Warnings: The updated labels will include stronger warnings about the potential cardiovascular risks associated with testosterone therapy. These warnings will highlight the increased risk of heart attacks and strokes in patients using testosterone, ensuring that both healthcare providers and patients are better informed.

Clearer Usage Instructions: To prevent off-label use, the new labeling guidelines emphasize that testosterone should only be prescribed to men with specific medical conditions leading to low testosterone levels. The FDA aims to reduce inappropriate prescribing and misuse of these products by making the intended use clearer on product packaging.

Adverse Event Monitoring Requirements: Manufacturers will be required to implement more robust pharmacovigilance processes, ensuring that adverse events related to testosterone products are tracked and reported with greater consistency.

Why Compliance is Critical

Failure to adhere to these changes could lead to regulatory penalties, product recalls, or delays in product approval. Beyond regulatory risks, inaccurate or non-compliant labels may lead to misinformed prescribing, increasing the risk of adverse outcomes for patients.

How to Prepare for the New FDA Labeling Guidelines

With the 2025 deadline approaching, organizations should take proactive steps to ensure they are ready for compliance:

Conduct a Label Audit: Review all existing labels for testosterone products to identify any discrepancies between current content and the new FDA requirements.

Update Labeling Workflows: Streamline your labeling process to incorporate the new requirements efficiently. Ensure that internal teams and external partners are aligned with the updated guidelines.

Leverage Automation and AI: Implement solutions that use automation and AI to detect potential errors, maintain consistency, and facilitate swift updates across multiple product lines.

Train Internal Teams: Ensure that regulatory teams, quality assurance departments, and other stakeholders are fully informed about the upcoming changes and understand how to maintain compliance.

How Veraciti Can Help You Stay Compliant

Staying compliant with evolving regulations can be complex, especially when managing large product portfolios across multiple regions. Kallik’s Veraciti offers a powerful end-to-end solution to simplify compliance, reduce manual effort, and minimize risk. Our AI-driven platform ensures that your labels remain accurate, consistent, and fully aligned with the latest FDA requirements.

✅ Automated Compliance Checks: Identify non-compliant labels instantly, reducing the risk of costly errors.
✅ Streamlined Label Updates: Roll out updates efficiently across all your product labels, ensuring consistent messaging and branding.
✅ End-to-End Traceability: Maintain a complete audit trail of all changes, giving you confidence during regulatory inspections.

Ready to Future-Proof Your Labeling Process?

Don’t wait until the deadline approaches. Contact us today or book a demo to speak with one of our experts and discover how Veraciti can help you ensure compliance with the FDA’s latest testosterone product labeling requirements. Not sure where to start with amending your artwork? Why not speak to one of our labeling and artwork management experts? Get in touch with a Kallik expert today by clicking here, emailing enquiries@kallik.com, or calling +44 (0) 1827 318100.
 

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