Artwork & Labelling Review

Overview

Product labels, cartons, package inserts, patient information leaflets, and other printed or electronic artwork must accurately reflect approved product information and applicable regulatory requirements.

Errors or inconsistencies in artwork can lead to mislabelling, regulatory observations, product complaints, recalls, or delays in approval and commercialization.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports pharmaceutical, biopharmaceutical, medical-device, and other regulated organizations with artwork and labelling review, content verification, change assessment, and lifecycle management support.

Our approach focuses on regulatory consistency, document accuracy, version control, traceability, and alignment between approved product information and final artwork.

Our Artwork & Labelling Services

Label & Artwork Review

Review of labels, cartons, foils, inserts, leaflets, and other packaging components for accuracy, completeness, and consistency.

Package Insert Review

Assessment of prescribing information, dosage instructions, warnings, precautions, contraindications, storage conditions, and other approved product information.

Patient Information Review

Review of patient-facing information to ensure consistency with approved content and applicable regulatory expectations.

Artwork Change Review

Assessment of proposed artwork or labelling changes to determine regulatory impact, documentation requirements, and implementation controls.

Content Consistency Check

Cross-checking of brand name, generic name, strength, dosage form, composition, manufacturer details, batch information, storage conditions, and other critical content.

Regulatory Alignment Review

Review of artwork against the latest approved dossier, product information, registration details, and market-specific requirements.

Version & Change Control Support

Support for maintaining artwork versions, approval status, revision history, and controlled implementation.

Multi-Market Artwork Coordination

Support for managing market-specific labelling requirements and maintaining consistency across different country versions.

Key Areas We Review

Depending on the product and market, MGS may review:

• Product name
• Generic / active ingredient name
• Strength and dosage form
• Composition
• Route of administration
• Indications
• Dosage instructions
• Warnings and precautions
• Contraindications
• Adverse reaction information
• Storage conditions
• Shelf life
• Batch and manufacturing information
• Manufacturer / marketer details
• Regulatory statements
• Pack size
• Barcode / coding information
• Symbols and mandatory statements
• Package insert content
• Patient information
• Version control
• Artwork approval status

Our Approach

• Understand the Product

Review the approved product information, target market, current artwork, and applicable regulatory requirements.

•  Compare

Cross-check artwork and labelling content against approved source documents.

• Identify Gaps

Highlight missing, outdated, conflicting, or incorrect information.

• Review Regulatory Impact

Assess whether proposed changes require regulatory notification, variation, approval, or internal change control.

• Finalize

Support correction, review, approval, and controlled finalization of the artwork.

• Maintain

Support lifecycle updates following regulatory changes, product changes, or revised approved information.

Deliverables

Depending on scope, MGS can provide:

• Artwork review comments
• Label compliance checklist
• Package insert review
• Patient-information review
• Content consistency assessment
• Change-impact assessment
• Artwork comparison report
• Version-control support
• Market-specific labelling review
• Final readiness review

Why Choose MGS

Regulatory & Quality Perspective

MGS reviews artwork with consideration of both regulatory requirements and quality-system controls.

Consistency Focus

Our approach helps reduce inconsistencies between approved documents, manufacturing information, and final packaging components.

Change-Control Integration

Artwork changes can be assessed alongside internal change control and lifecycle regulatory requirements.

Practical Review

Findings are communicated clearly so clients can correct issues before approval, printing, or implementation.

Lifecycle Support

MGS can support initial artwork review as well as ongoing updates throughout the product lifecycle.

Who We Support

MGS can provide artwork and labelling review support for:

• Pharmaceutical companies
• API and finished dosage form organizations
• Biopharmaceutical companies
• Medical-device organizations
• Marketing Authorization Holders
• Product developers
• Contract manufacturers
• Packaging and artwork teams