Regulatory Artwork and Labeling Services

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.

Pharma Wizard supports labeling and artwork development and management across multiple countries using its centralized team of subject matter experts (labeling, medical, safety, etc.), quality, process excellence, design, and operations teams, coupled with regional regulatory experts. Both central and regional teams are governed by Pharma Wizard’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.

Pharma Wizard has regional regulatory labeling and artwork experts based in 120+ countries who review new labels, artworks, advertisement, and promotional materials—as well as any changes—to assess them against local health authority regulatory requirements and ensure compliance with specifications.