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3 min read
As pharmaceutical portfolios expand at a record pace, one critical function is feeling the pressure, and that is Packaging Artwork Operations. Often overlooked, this function is central to ensuring compliance, speed-to-market and brand integrity across global markets. At the heart of this complexity lies packaging artwork management—a multi-functional, multi-stakeholder engagement that ensures packaging and labeling components are not only compliant but also accurate, market-specific, and ready for distribution on time.
A matrix showing portfolio drivers vs. artwork impact
Portfolio Expansion: What’s Driving the Change?
As pharma companies strive to meet the needs of global and local markets, they launch more products in different formulations, pack sizes, and strengths. These expansions are driven by:
- Increasing demand for specialty and generic drugs
- Broadening global access and localization efforts
- Fast-evolving regulatory landscapes and compliance requirements
- Country-specific tariffs and import duties that impacts product pricing, market entry strategies and packaging variations
While this growth is necessary for competitiveness, it directly amplifies the need for efficient and agile artwork management. The inclusion of country-specific tariff considerations means that packaging designs may require frequent adjustments to reflect local sourcing, manufacturing shifts or distribution changes, adding another layer of complexity to artwork operations.
Example: In Brazil, pharmaceutical imports can face tariffs of up to 14% depending on product classification under Mercosur’s Common External Tariff (CET) rules. This often drives companies to consider local manufacturing or secondary packaging within the country to reduce import costs, which requires dedicated packaging artwork adapted to local regulatory language, labeling standards, and distribution requirements.
Why Portfolio Growth Fuels Artwork Operations
Modern pharmaceutical companies are diversifying their portfolios through:
- Launches across multiple dosage forms and pack sizes
- Expansion into new geographies and regulatory jurisdictions
- Introduction of branded generics, OTC, biosimilars, and digital therapeutics
- Portfolio consolidations and acquisitions
Each of these moves introduces new or modified packaging requirements, resulting in a proliferation of artwork files, components, and regulatory checks. The complexity increases exponentially when operating across multiple markets and product lines.
The Growing Challenges in Artwork Operations
Pharma companies are now facing a range of challenges as they try to keep up with the pace of portfolio-driven artwork demands. These challenges stem not just from volume, but also from regulatory and operational intricacies.
Here is a breakdown of common challenges arising from various dimensions of portfolio growth:
| Challenge Area | Description | Examples | Impact |
| Multi-market Regulatory Complexity | Different countries have unique regulatory guidelines for packaging, labeling, and serialization. | EU FMD vs. US DSCSA vs. Saudi Arabia SFDA serialization requirements | Increases compliance risk and requires market-specific artwork variations, extending timelines and raising operational costs. |
| Same-market SKU Expansion | Launching multiple variants within a single market increases SKU-specific artwork and label requirements. | Pediatric vs. adult formulations, or 10-tab vs. 30-tab packs | Escalates artwork volume, increases proofing workload and raises the potential for labeling errors. |
| Supply Chain Complexity | Increased touchpoints in the supply chain demand precise, timely, and synchronized artwork updates. | Variants for cold chain vs. ambient shipping, or different CMOs per region | Delays or misalignment can lead to shipment holds, product wastage or regulatory non-compliance. |
| Labeling Change Management | Frequent regulatory updates or safety labeling changes need artwork updates across entire product families. | Safety updates post-pharmacovigilance findings; CCDS alignment | Delays in implementing updates can result in recalls, fines or market withdrawal. |
| Parallel Launches | Simultaneous launches across regions compress timelines and increase chances of non-compliance. | Global vaccine rollout scenarios or emergency drug launches | Heightened risk of missed deadlines, inconsistent labeling and market launch delays. |
| Vendor & CMO Coordination | Multiple partners may be responsible for packaging and labeling, requiring centralized artwork governance. | Third-party vendors using outdated templates or unapproved changes | Poor coordination can cause quality lapses, duplicate work and regulatory breaches. |
| Language and Translation Management | Expanding into new markets requires translation and localization of labels, inserts, and cartons. | Launching in multilingual EU countries or LATAM markets | Translation errors can lead to mislabeling, patient safety risks and market penalties. |
| Version Control and Proofing | Managing artwork revisions and preventing errors requires robust systems and audit trails. | Version mix-up during proofing; approval lapses leading to product recall | Increases recall risk, damages brand reputation and can lead to regulatory sanctions. |
The Need for Centralized Artwork Governance
To counter these challenges, pharma companies are increasingly moving toward:
- Centralized artwork hubs or shared services to standardize and streamline processes
- Regulatory-compliant proofing tools and version control systems
- Integrated project management workflows connecting regulatory, supply chain, Packaging, QA, and marketing teams
- Artwork process consulting to assess gaps, optimize workflows, and enhance compliance
At Freyr Solutions, we specialize in end-to-end regulatory artwork services that cater to these growing needs—from artwork operations to regulatory submission and multi-country coordination. Our centralized delivery model and deep regulatory expertise ensure that your portfolio growth does not come at the cost of compliance or operational efficiency.
Final Thoughts
Pharma portfolio expansion is a sign of innovation and market growth. But it also demands strategic alignment of artwork operations to navigate regulatory, supply chain, and commercial complexities. The right artwork partner can make all the difference—ensuring faster market readiness, error-free packaging, and seamless compliance across regions.
Whether you're launching in 5 markets or 50, Freyr’s centralized artwork services help you stay compliant, agile and launch-ready—every time. Let’s talk about how we can future-proof your artwork operations.
