Service Overview

Our Regulatory Affairs service offers end-to-end support for product registration and lifecycle management. We specialize in navigating the diverse regulatory requirements of African health authorities, ensuring your submissions are compliant and timely. From initial application to post-approval maintenance, we are your dedicated regulatory partner.

Key Features

We provide comprehensive support for New Product Authorizations, including dossier preparation and submission in accordance with local requirements. Our Lifecycle Management services ensure your products remain compliant through variations, renewals, and other post-approval changes. We also facilitate direct interaction with Health Authorities, managing communications and responding to queries to expedite approvals. Trust us to handle the complexities of regulatory compliance so you can focus on your core business.

Benefits

By partnering with us, you can accelerate your time to market and reduce the risk of regulatory delays. Our proactive approach to compliance ensures your products maintain their market authorization without interruption. With our expertise, you can confidently expand your footprint in the African market, knowing that your regulatory obligations are in capable hands.