,
1 min read
The artwork and labeling functions are under constant pressure to meet the increasing demand for reducing the time-to-market of drugs/devices. Besides time-bound pressures, the accuracy needed to be aligned with health authority validation requirements challenges organizations’ compliance with artwork pack management capabilities. Even a single error might result in product recalls, fines, and heavy cost burdens.
In today’s global regulatory environment (2024–2025), the focus on error-free pharmaceutical labeling, compliant packaging artwork, and structured artwork governance has intensified across regulated markets such as the US, EU, UK, Canada, GCC, and APAC. Health authorities, such as the FDA, EMA, MHRA, and TGA, continue to tighten expectations regarding labeling accuracy, serialization, and artwork change control.
Besides the need to ensure that systems are compliant, audit-ready, and cost-efficient, there’s also a growing need for regular updates in the Regulatory Labeling & Artwork domain. To effectively manage its requirements across all major divisions of the pharmaceutical spectrum, the need of the hour is a robust Artwork Management System that is scalable and constantly evolving to meet the growing needs of a given organization.
Modern artwork operations now rely heavily on digital artwork management tools, AI-driven proofreading, centralized artwork repositories, cloud-based AMS platforms, and automated quality checks to minimize compliance gaps and accelerate artwork cycle times.
Right from proofreading, graphic designing, artwork management, to change management, what Pharmaceuticals, Biotechnology, and Medical Devices companies require is a comprehensive artwork management system and compliant proactive advice to:
- centralize and standardize end-to-end pharmaceutical artwork creation process
- strategize the reduction of artwork changes globally
- compliant artwork process and system implementation
Organizations are increasingly adopting artwork process consulting, workflow automation, and standardized global artwork SOPs to streamline these activities.
Here are some of the artwork touchpoints that you might require a specialized partner to work on:
- Primary and Secondary Artworks for Cartons, Blister Foils, Tubes, Sachets, Labels, etc.
- Patient Information Leaflets (PIL) Design
- Specialist proofreading and review
- Design & Layout Creative Services
- Scientific & Medical Books Typesetting
Additional touchpoints now include multi-market packaging adaptation, regulatory content harmonization, digital label (ePIL/e-label) preparation, QR code integration, and multilingual artwork translation services — all essential for global compliance.
As the world rapidly becomes automated, there are compliant pathways and packaging management systems that companies can adapt to ensure compliance in a timely and cost-effective manner. Leverage them right away. You may be interested in reviewing this proven case study of Freyr, which outlines the end-to-end artwork services used to complete 395 CRRs.
Organizations partnering with expert regulatory artwork service providers can now reduce artwork cycle times by up to 40%, improve Right-First-Time (RFT) rates, and enhance global brand integrity while ensuring regulatory compliance.
