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3 min read
In today’s fast-paced pharmaceutical landscape, artwork operations are no longer a backend task—they’re a frontline enabler of compliance, speed-to-market and brand trust. At Freyr, we’ve seen firsthand how a well-crafted strategy can transform artwork from a bottleneck into a competitive advantage.
Why Do Artwork Operations Need a Robust Strategy?
Pharmaceutical artwork is more than just packaging design — it is a tightly regulated, high-stakes operation involving multiple stakeholders across geographies and departments. Without a clear and cohesive strategy, companies often face:
- Regulatory non-compliance, leading to delays or market withdrawals
Example: In 2020, a European regulator ordered an immediate market withdrawal of a chronic disease drug after incorrect dosage instructions were discovered on the carton. The error delayed re-launch by three months and cost the company over €12 million in lost sales and relabeling costs. - High error rates, resulting in costly recalls and reputational damage
Example: A major US pharma company recalled 650,000 bottles of a popular over-the-counter product because the ingredient list was misprinted. The public recall notice received widespread media coverage, causing a significant drop in brand trust and leading to lawsuits from consumer groups. - Operational inefficiencies, such as extended artwork cycle times and manual reworks
Example: A global vaccine manufacturer experienced a six-week launch delay in Asia when final artwork approvals required manual proofing across eight languages, creating bottlenecks in their regulatory clearance process. This directly affected market share in a competitive tender. - Supply chain disruptions, due to misaligned or delayed artwork deliverables
Example: A specialty pharma company halted production for two weeks because updated carton designs failed to meet the print vendor’s dieline specifications. This resulted in stock-outs at pharmacies in two key markets. - Fragmented communication, primarily when teams work in silos across global sites
Example: In one multi-country launch, the marketing and regulatory teams approved different label versions due to misaligned change controls. This led to a recall in one market and emergency reprinting in another, increasing costs by 40%.
A robust strategy helps organizations address these challenges by standardizing processes, leveraging the right tools, ensuring quality and compliance, and fostering a culture of continuous improvement.
Eight Pillars of Pharma Artwork Operations Strategy
| Pillar | Description | Specific Considerations |
| Artwork Management System (AMS) | Centralizes and streamlines artwork activities, from creation to approval and archiving. | - Integration with regulatory systems - User-friendly interface - Configurability |
| Quality Assurance | Ensures accuracy, consistency, and compliance with regulatory and corporate guidelines. | - Multi-tier reviews - Electronic proofing - Error tracking |
| Advanced Technology & Automation | Leverages digital tools to automate repetitive tasks, reduce errors, and accelerate workflows. | - Automate artwork creation - Automation technology roadmap |
| Continuous Improvement | Regularly enhances processes through feedback, analytics, and performance measurement. | - KPI tracking - Root cause analysis - Routine training sessions |
| Audit, Traceability & Compliance | Facilitates comprehensive documentation and traceable actions for regulatory audits and transparency. | - Digital audit trails - Version control - reporting |
| Regulatory Compliance | Ensures all artwork aligns with regional and country-specific regulations and product requirements. | - Regulatory intelligence updates - Local regulatory expertise |
| Print Vendor Compliance | Aligns artwork files and specifications with supplier capabilities and mandates. | - Print-ready file verification - Vendor qualification - Technical checks |
| Sustainability | Promotes environmental responsibility and resource-efficient packaging design. | - Material optimization - Digital innovations for sustainability - Supply Chain Efficiency & Waste Reduction |
Why Strategic Artwork Planning Matters
A proactive artwork strategy ensures:
- Fewer packaging errors
- Faster product launches
- Improved team collaboration
- Regulatory peace of mind
- Stronger brand integrity across markets
Successful Case Study - Transforming Pharma Artwork Operations with Freyr’s 8 Pillar Strategy
Client: Global Specialty Pharma Company | Markets: 15 | Duration: 9 Months
Challenge
The client faced:
- Low RFT accuracy (14%), causing costly reworks.
- 55-day cycle times delaying launches.
- Vendor misalignment and print rejections.
- Siloed regional operations and compliance gaps.
Freyr’s Solution
Applied the 8 Pillars Framework to create a future-ready artwork strategy:
- AMS Integration with RIM & PLM for centralized workflows.
- QA and multi-tier reviews.
- Electronic tools for multilingual proofing
- Compliance Controls with pre-submission checklists and regulatory updates.
- Vendor Standardization through dieline templates and qualification.
- Sustainability via digital proofing and color optimization.
Results (within 6 months)
- RFT Accuracy: ↑ from 14% to 97%
- Cycle Time: ↓ from 55 to 22 days
- Recalls: Reduced to zero
- Regulatory Delays: ↓ 80%
- Sustainability Gains: Saved 2.5 tons of paper/year
Conclusion
As product portfolios expand and regulations become more dynamic, organizations need to reimagine artwork operations not as a backend function, but as a strategic enabler of compliance, speed, and quality. By focusing on the right pillars — AMS, technology, quality, compliance, sustainability, and continuous improvement — companies can future-proof their operations and drive competitive advantage.
Whether scaling globally or launching locally, your artwork strategy can make or break your success. Let Freyr help you build a future-ready artwork operation that is compliant, efficient and built for growth. Contact us to explore tailored solutions.
