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Artixio

Regulatory Artwork Labeling

Regulatory Artwork and Labeling Services

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

Global Artwork and Labeling Compliance Services by Artixio

At Artixio, we have been working with leading pharmaceutical and biotech companies in more than 120 countries and helping their products enter markets. Regulatory Labeling and artwork play an important role in making sure your product communicates the right information and meets regulatory expectations in every country.

Our Highly experienced Labeling consultants bring the global experience and hands-on know-how together, support everything from first mock-up to market-ready packaging. Whether it is a prescription medicine, medical device, diagnostic kit, cosmetic, nutraceutical, OTC, or even a veterinary product, our team knows how to manage the details that matter.

Global Regulatory Labeling Strategy & Consulting

Development

Commercial

Global Regulatory Intelligence for Artwork and Packaging Strategy

Global, KPI Driven Labeling and Artwork Services 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.

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.

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.

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.

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.

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Specialized Artwork and Labeling Services Across Multiple Industries

Regulatory and compliance expert – Artixio

Pharmaceuticals

Medical device regulatory services – Artixio

MedTech

Cosmetics regulatory consulting – Artixio

Cosmetics

Nutrition regulatory consulting – Artixio

Nutrition

Biologics regulatory consulting – Artixio

Biologics

Veterinary regulatory consulting – Artixio

Veterinary

Expert Regulatory Services To Streamline Compliance

GxP Compliance Regulatory monitoring services
Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review

Regulatory Services Across Multiple Countries

India Artixio – Regulatory affairs consulting expert

India

Singapore Artixio – Regulatory affairs consulting expert

Singapore

Mexico Artixio – Regulatory affairs consulting expert

Mexico

Brazil Artixio – Regulatory affairs consulting expert

Brazil

Vietnam Artixio – Regulatory affairs consulting expert

Vietnam

Malaysia Artixio – Regulatory affairs consulting expert

Malaysia

Argentina Artixio – Regulatory affairs consulting expert

Argentina

Colombia Artixio – Regulatory affairs consulting expert

Colombia

Taiwan Artixio – Regulatory affairs consulting expert

Taiwan

China Artixio – Regulatory affairs consulting expert

China

Europe Artixio – Regulatory affairs consulting expert

European

Thailand Artixio – Regulatory affairs consulting expert

Thailand

Indonesia Artixio – Regulatory affairs consulting expert

Indonesia

Philippines Artixio – Regulatory affairs consulting expert

Philippines

USA Artixio – Regulatory affairs consulting expert

USA

Japan Artixio – Regulatory affairs consulting expert

Japan

Qatar

South Korea

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