Ensuring Compliance Across Diverse Labelling Requirements
Customer Requirement
A pharmaceutical company required preparation and completion of 55 packaging artworks for submission and commercialization across multiple African countries.
The client needed assurance that each artwork complied with country-specific regulatory requirements while maintaining accuracy in labeling, multilingual content, and brand consistency. The deliverables also needed to be completed within defined timelines to support planned market entry.
Problem Statement
The client faced several complexities due to the diversity and scale of the project, including:
- Variations in labelling and packaging requirements across different African countries
- Management of multilingual content, including English, French, Portuguese, and regional languages
- Ensuring accuracy of critical safety information such as dosage, warnings, and storage instructions
- Maintaining consistency across a high volume of artworks
- Risk of delays or regulatory observations due to errors or non-compliance
These challenges increased the risk of rework, approval delays, and potential disruption to product launch timelines.
Key Objective
To develop and complete 55 regulatory-compliant artworks aligned with country-specific requirements, ensuring accuracy, multilingual consistency, and readiness for regulatory submission and commercialization.
Regulatory Support & Outcome
A structured approach was followed to review country-specific labelling requirements and assess artwork content accordingly. Templates were adapted to reflect regional regulatory expectations while maintaining consistency in product information and presentation.
Multilingual content was reviewed and validated to ensure accuracy and alignment with regulatory and safety requirements. Multi-level checks supported identification and correction of inconsistencies before finalization.
This approach enabled timely completion of artworks while supporting compliance and reducing the likelihood of regulatory concerns.
Business Impact
- 55 artworks were completed within the planned timelines
- Improved alignment with country-specific regulatory expectations
- Reduced risk of labelling-related regulatory queries
- Strengthened readiness for submissions and product launches
- Improved efficiency in managing multi-country artwork projects
Key Learning
Preparation of packaging artworks for multiple African markets requires careful alignment with diverse regulatory requirements and strong control over multilingual content. Early planning and structured review processes help ensure compliance, accuracy, and timely market readiness.