Project Overview

ECP provided critical regulatory intelligence and strategic guidance for GSK's complex vaccine divestment initiative and broader pharmaceutical operations restructuring across Sub-Saharan Africa. Our expertise in African regulatory landscapes enabled smooth transitions and compliance adherence. The project involved multi-faceted regulatory support including market analysis, regulatory pathway mapping, and compliance strategy development for both existing products and new market entries.

Key Achievements

• Vaccine Divestment Support: Provided regulatory strategy for PAREXEL's GSK Vx Divestment project, ensuring compliance across multiple jurisdictions
• Market Strategy Development: Developed comprehensive regulatory strategies for Kenya and Nigeria markets, addressing specific country requirements
• Operations Restructuring: Supported restructuring of pharmaceutical operations across Sub-Saharan Africa with regulatory compliance guidance
• Regulatory Intelligence: Delivered up-to-date regulatory intelligence on changing requirements across African markets
• Compliance Framework: Established robust compliance frameworks for ongoing operations in target markets

Impact & Results

Our involvement in the GSK projects resulted in streamlined regulatory processes, reduced time-to-market for critical products, and enhanced compliance posture across Sub-Saharan African operations. The strategic guidance provided enabled GSK to navigate complex regulatory environments while maintaining operational efficiency. The project success demonstrated ECP's capability to handle large-scale, multi-jurisdictional regulatory challenges for global pharmaceutical leaders.