Pharma companies deal with constant label updates, global regulatory requirements, and coordination across internal teams, suppliers, and regulators. Managing Artwork & Labeling process manually or with generic tools, is slow and risky. Without a structured system in place, errors slip through and timelines get stretched.
This is where specialized pharma artwork and labeling management software comes in. In this guide, we’ve rounded up 16 of the best artwork and labeling management software for pharma.
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What Is A Pharma Artwork & Labeling Management Software?
In pharma, when people say “artwork and labeling,” they’re really talking about all the stuff that goes on a box, bottle, or leaflet — the design, the text, the warnings, even the little dosage instructions. It’s not only about how the pack looks, it’s also about making sure regulators and patients get the right information. And because one mistake can mean a recall, companies have to manage this very carefully.
Best Pharma Labeling Management Software
1. NiceLabel (By Loftware)- The NiceLabel Label Management System standardizes your entire label printing process into one platform. It includes everything you need to transform your labeling processes. NiceLabel’s Label Management System includes a label designer, document management system, application builder, web printing system (for manual printing), integrated printing system, a non-production environment and a change and transport system. It scales from five users to thousands and can be extended to remote locations, suppliers or contract manufacturers.
2. BarTender (By Seagull Scientific)- When you’ve got challenges like DSCSA, FMD, traceability, counterfeiting and tampering and 21 CFR Part 11, you need a trustworthy labeling software like BarTender (Professional, Automation and Enterprise). We support pharmaceutical companies from global, Fortune 500 manufacturers to small nutraceutical packagers, managing critical regulatory compliance.
3. Teklynx Labelling (By Teklynz Newco SAS)- TEKLYNX software enables electronic signatures and automated label tracking, which is critical in such a highly regulated industry. Whether it’s medicine and drug labeling, or lab sample tracking, we have a labeling solution that can seamlessly integrate into your supply chain operations.
Also Read: What Is Computer Software Assurance (CSA)
4. Label 360 (By Freyr Solutions)- Freyr LABEL 360 is one such comprehensive label life cycle management tool through which companies can manage the label changes globally in a streamlined and timely manner. The overarching principle of Freyr LABEL 360 is to integrate industry best practices by bridging the gaps within the global and regional labeling processes and to control the flow of labeling information from core label change to regional label implementation through artwork, supply chain and printing phases.
5. Siemens Artwork & Labelling (By Siemens)- Our artwork and labeling solutions for the pharmaceuticals industry support internal and external collaboration, allowing for efficient change management. By providing updated, accessible design information, your creative team can truly concentrate on their core purpose: being creative.
6. Veraciti TM Artwork & Labelling (By Kallik)- Our software, Veraciti, is designed to help your organization manage all labeling and artwork, maintain compliance and increase speed to market. Our interactive diagram below will take you through the processes on our end-to-end system.
7. Artwork Flow Label (By Bizongo)- Artwork Flow helps life science,pharm,cosmetics and chemical companies adhere to strict regulatory compliance across different geographies and collaborate with distributed teams across the supply chain.
8. Prisym 360 (By Prisym ID)- PRISYM 360 enables a revolutionary 360° outlook of your master data assets and provides the ability to control and optimize them to create a fully integrated approach to label management along the complete lifecycle, from design to inspection.
9. Blue Software (By Esko-Graphics)- BLUE’s SaaS label and artwork management applications simplify the label and packaging process through automated workflow templates, online proofing tools, and digital asset management.
Top Artwork Lifecycle Management Software
10. Webcenter Artwork & Labelling (By Esko)- A collaborative workflow solution that guides your team through the process of bringing consumer products to market – from content creation to distribution.
11. Manage Artwork (By Karomi)- ManageArtworks is a cloud-based packaging and artwork lifecycle management system. It connects people and processes across internal departments, customers, suppliers, agencies and vendors to get products faster to the market while meeting regulatory compliance.
12. Loftware SmartFlow (By Loftware)- Smartflow Artwork Management software lowers costs, reduces mistakes, improves collaboration and reduces time to market. Smartflow transforms project management, streamlining the packaging concept to shelf process by bringing accountability and structure to the process. Loftware’s comprehensive Smartflow platform enables you to manage packaging artwork and the end-to-end business processes, mitigating risk, improving control, compliance, traceability and reducing the overall complexity of the artwork management process.
13. Glams Enterprise AMS (By GLAMS-Perigord)- Global Labelling Artwork Management System (GLAMS) is a process driven, scalable and fully validated system that helps eliminate errors and regulatory noncompliance on a global level.
14. ArtWork PLM (By Freyr Solutions)- Product Lifecycle Management (PLM) tool is a good bet for any type of organization. With a robust artwork management system installed, an organization can build their artwork lifecycle workflow to track each stakeholder’s tasks and even be audit-ready.
15. Twona AMS (By Twona)- Twona AMS focuses on delivering an Artwork Management Software (AMS) that makes your life easier. Gain the benefits below without losing the familiarity of your own workflow — maximizing your productivity is easier than you think.
16. Harmony’s Pakaging & Artwork Management (By GreatFour Systems)- Harmony’s Packaging and Artwork Management solution we can intelligently configure your system in days. Imagine migrating your existing data and a launch within days that is fully compliant with 21 CFR part 11 regulations, EU Annex 11 guidelines and other markets regulations.
Also Read: Best Regulatory Information Management Software
Pharma Labeling Requirements by Country
Labeling rules aren’t the same everywhere. Each country has its own regulator and its own checklist for what needs to appear on a medicine pack or leaflet. Below is a quick snapshot of major markets with links to full guides for deeper details.
- India — CDSCO: Drugs & Cosmetics Rules, QR/serial rules on select products, local language where required. Read CDSCO Labeling Requirements
- Thailand — Thai FDA: Thai language core data, labeling/leaflet approvals.
- South Korea — MFDS: Korean language, e-leaflet pilots, serialization scope.
- Singapore — HSA: local labeling standards, patient info leaflets, barcoding.
- Malaysia — NPRA: Bahasa Malaysia/English labeling, med info leaflet, hologram usage.
- Indonesia — BPOM: Bahasa Indonesia, registration number display, leaflet format.
- China — NMPA: Chinese language labels, pack insert specs, track & trace codes.
- Japan — MHLW/PMDA: package insert (添付文書), Japanese language, barcode/trace rules.
- Philippines — FDA Philippines: English/Filipino as applicable, lot/expiry prominence.
- Qatar — MOPH: Arabic/English labeling, import pack rules. Read Regulatory Labeling Requirements of Health Supplements in UAE
- Kuwait — MOH: Arabic/English, registration number display.
- Oman — MOH: Arabic/English labeling, leaflet standards.
- Bahrain — NHRA: Arabic/English labeling, batch/expiry visibility.
- Turkey — TİTCK: Turkish labeling, safety features, leaflet readability.
- Switzerland — Swissmedic: DE/FR (often two official languages), patient info leaflet.
- Israel — MOH: Hebrew/English/Arabic context-based, leaflet/insert rules.
- Brazil — ANVISA: Portuguese labels, RDC labelling rules, SNCM serialization.
- Mexico — COFEPRIS: Spanish labeling, box/leaflet alignment, lot/expiry size. Read COFEPRIS Labeling Requirements for Food Supplements
- Argentina — ANMAT: Spanish labels, national code display, leaflet format.
- Colombia — INVIMA: Spanish labeling, registration number, warnings.
- Chile — ISP: Spanish labels, local warning statements.
- South Africa — SAHPRA: English labeling (others allowed), patient info leaflet, serial rules.
- Peru — DIGEMID: Spanish labeling, leaflet approval scope.
- Vietnam — DAV: Vietnamese labeling, registration number on pack.
- Russia — Minzdrav/Roszdravnadzor: Russian labels, serialization/Chestny ZNAK track-and-trace.
- Ukraine — State Service of Medicines: Ukrainian language, national code display.
- United States — FDA (CDER/CBER): drug facts/PI, serialization (DSCSA), 21 CFR parts for labeling.
- European Union — EMA + National CAs: QRD templates, safety features (2D code + anti-tamper), Braille on outer pack.
- United Kingdom — MHRA: post-Brexit alignment with EU-style packs, patient leaflet, Braille.
- Canada — Health Canada: English/French labeling, plain-language labelling, DIN on pack.
- Australia — TGA: TGO 91/92 labelling standards, APIN/ARTG references on labels.
- New Zealand — Medsafe: NZ data sheet/CMI alignment, readability, batch/expiry.
Also Read: Cosmetic Labeling Requirements
Benefits of Using Pharma Artwork & Labeling Management Software
Using spreadsheets and email threads to handle artwork in pharma is a recipe for mistakes. One typo or missing update in a patient leaflet can turn into a recall, and nobody wants that. This is why many pharma teams are moving toward proper artwork and labeling management software. Some of the real-world benefits include:
- Fewer mistakes that cost money
When every label version is tracked, it’s harder for the wrong file to slip through. That alone saves on reprints and potential compliance issues. - Better compliance with regulators
FDA, EMA, Health Canada — they all have their own rules. A good system keeps audit trails and logs so you can show exactly who approved what and when. - Time saved on approvals
Instead of chasing signatures over email, teams can route files inside the software. That means launches don’t get held up waiting for one missing sign-off. - Collaboration without chaos
Packaging, regulatory affairs, vendors, even printers — they can all work in the same space instead of trading files back and forth. - Clear visibility into the process
Managers don’t have to guess where things are stuck. Dashboards in many tools show which artwork is pending, approved, or overdue. - Scales with your growth
For smaller companies, it might start as a simple artwork management system. For global pharma, it becomes a packaging artwork management platform that supports multiple countries and languages.
How to Choose the Right Artwork & Labeling Software?
Choosing a pharma artwork management system isn’t straightforward. Big firms need one thing, smaller teams need another, and compliance rules make it even trickier. Here are a few angles to think about before picking.
- Company size matters
A global pharma company usually needs a global artwork management system that supports multiple markets and languages. Smaller businesses might prefer a leaner artwork management tool that just handles version control and approvals without extra complexity.
- Workflow complexity
Big teams often need full-blown artwork workflow management — dashboards, role-based approvals, automated proofing. For a small regulatory team, that could be overkill.
- Regulatory coverage
If your products are going out in the US, EU, or Asia, don’t assume one system will automatically cover you. Some tools have proper regulatory labeling software modules that match FDA or EMA rules, but others are more generic. Double-check that before you commit, otherwise you’ll be patching things later.
- Integration with other systems
Most pharma teams already run on PLM, ERP, or MES. If the artwork platform can’t connect to those, you’ll waste hours copying data back and forth. Ask upfront how it plugs in — API, connectors, or nothing at all.
- Scalability and budget
Cloud platforms usually make it easier to start small and then grow as you add more products or markets. But not every company is comfortable putting regulated data in the cloud. If your IT team is strict, you might need an on-prem setup, even if it costs more to maintain.
- Audit readiness
Don’t underestimate this. An auditor will ask who approved a leaflet, when, and under what SOP. A good artwork management system for pharmaceuticals should be able to show that instantly.
Also Read: What Is Structured Product Labeling
Conclusion:
Managing artwork and labeling in pharma isn’t just about design — it’s about compliance, safety, and speed to market. With tighter global regulations and more complex supply chains, relying on spreadsheets or generic tools is no longer enough. That’s why more companies are turning to dedicated pharma artwork management software and labeling management systems to stay audit-ready and reduce costly errors.
The tools we listed — from enterprise-grade packaging artwork management software to lightweight pharma labeling software — give teams a single place to handle artwork changes, track approvals, and keep every label version under control. Whether your priority is regulatory labeling compliance, artwork lifecycle management, or smoother collaboration across packaging and supply chain teams, there’s a platform here that can fit.
At the end of the day, the “best” label and artwork management software isn’t the same for everyone. A large pharma company that sells in dozens of countries will probably need a full global artwork management system with heavy compliance features, while a smaller business may just want a straightforward artwork management tool that keeps version control simple.
The main point is this: the right pharma artwork management software saves time, cuts down on errors, and helps your labels pass regulatory checks without last-minute stress. It also makes life easier for your teams, whether they’re in packaging, regulatory affairs, or manufacturing. Picking one now is less about chasing features and more about finding what actually works for your workflow.
