Project Overview

ECP served as the primary regulatory consultant for Grünenthal's entry and expansion in the Kenyan pharmaceutical market. Our team provided end-to-end regulatory support for branded generic products, ensuring compliance with Kenya's Pharmacy and Poisons Board requirements. The project focused on establishing a robust regulatory framework for product registration, market authorization, and ongoing compliance maintenance for Grünenthal's portfolio of pain management and specialty pharmaceutical products.

Key Achievements

• Product Registration: Successfully managed the registration process for multiple branded generic products with the Pharmacy and Poisons Board
• Regulatory Strategy: Developed comprehensive regulatory strategies tailored to Grünenthal's product portfolio and market objectives
• Compliance Management: Established systems for ongoing regulatory maintenance and compliance monitoring
• Market Intelligence: Provided up-to-date regulatory intelligence on changing requirements and market dynamics
• Stakeholder Engagement: Facilitated communication and relationships with regulatory authorities and key stakeholders

Impact & Results

Our partnership with Grünenthal resulted in successful market entry and sustainable operations in Kenya. The regulatory framework we established enabled smooth product registrations and maintained compliance with local regulations, supporting Grünenthal's strategic objectives in the East African market. The project demonstrated ECP's capability to support global pharmaceutical companies in navigating complex regulatory environments while ensuring business continuity and market success.