Artwork and Labeling Services

Global Labeling and Artwork Services supporting product lifecycle from Development to Post Commercialization

Services We Offer

Artixio For Your Artwork and Labeling Services

Leveraging insights from our experience working with global pharmaceutical and biotech leaders, Artixio’s services enable patient access and convenience to innovative products through label & artwork development and maintenance services in 120+ countries. Artixio’s team is a unique mix of global labeling and artwork support from concept to market to industries ranging from pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, veterinary, over the counter (OTC) and consumer health products.

Global Labeling Strategy & Consulting

Development

Commercial

Company Core Data Sheet (CDS) Authoring
CDS Review and Proof Reading
Regional Labeling Services (Product Information Leaflets, PIL, SmPC etc)
Label Change Management
Structured Product Labeling
Clinical and Non Clinical Over Authoring to Support Labeling Changes
Visual Quality Check of Label

Global Regulatory Intelligence for Artwork and Packaging Strategy

Global, KPI Driven Labeling and Artwork Services Excellence:

Supporting Global Top 20 Pharma, Small and Medium Sized Pharma/Biotech
Wide therapeutic area and product category experience
Central-Regional Regulatory Experts for Multi-Country Labeling Requirements
Regional Regulatory Insights to Support International Labeling and Artwork Review
Experience with leading Artwork Management technologies such as Veeva
Leadership Experience in Implementing Large Scale Labeling & Artwork Multi-Year, Multi-Million programs
Compliant with GxP standards, ISO 9001: 2015 Certified Company
KPIs and SLAs Driven Service Delivery Excellence

FAQS About Artwork and Labeling Services

What are key components of global labeling and artwork?

Global labeling of pharmaceutical, medical devices, cosmetics, nutraceutical and consumer products essentially covers the product details including manufacturing, usage, safety, precautions, side effects, dosage and other information as specified by the health authorities around the world. Labels and artworks need to be approved by the health authorities to ensure they comply with regulations and are helpful to patients/consumers to understand the nature of the products and their usage under applicable circumstances.

How do you support labeling and artwork across multiple countries?

Artixio supports labeling and artwork development and management across multiple countries using its centralized team of subject matter (labeling, medical, safety etc.), quality, process excellence, design and operations teams coupled with regional regulatory experts. Both central and regional teams are governed by Artixio’s proven processes for excellence in artwork and label lifecycle management from development to commercialization.

What challenges do companies face in global labeling & artwork and how do you address them?

The challenges companies face in managing global labeling and artwork include, but not limited to, lack of experience in development of labels/target product profile/ core data sheet for specific therapeutic area, resources for thorough literature review (clinical and non clinical) for molecules, therapy area and articulate authoring of content for patient access and health authority approvals. Companies also face challenges in managing large volume of artwork and label quality check, review as they work with multiple departments and graphic design vendors.

Often artwork and label submissions have strict health authority submission deadlines that require large teams working 24×7 to develop multiple iterations of the documents in short span of time. Large organizations with products in multiple markets need to ensure their labels and artworks comply with regional regulations. All these factors lead to increase in cost of managing multiple versions of the labels and artwork for each product in multiple markets, therefore, they seek cost effective solutions.

How does your team manage international labeling and artwork?

Artixio has regional regulatory labeling and artwork experts based in 120+ countries who review new labels, artworks, advertisement and promotional material as well as any changes to assess against the local health authority regulatory requirements to ensure they comply with specifications.

How do you stay updated with global regulatory changes impacting label and artwork? 

Artixio has inhouse regulatory intelligence platform that tracks changes in regulations worldwide that can potentially impact the label and artwork. Artixio’s regulatory intelligence team monitors global health authority websites, generates insights from regional health authority directives, seminars, trade association meetings to identify potential changes that may trigger label and artwork updates.