Case Study: German Multinational Pharmaceutical and Life Sciences Company achieves successful OTC market switch in Brazil with FREYR

German Multinational Pharmaceutical and Life Sciences Company achieves 100% ANVISA compliance with FREYR

A German multinational pharmaceutical and life sciences company faced the challenge of switching a topical product from prescription to over-the-counter status in Brazil. They needed to navigate ANVISA's stringent regulatory framework, including RDC 98/2016, without prior Brazilian market data. The company engaged FREYR for its regulatory strategy and dossier development services to build a locally compliant submission and avoid delays.

FREYR compiled a full OTC switch dossier by leveraging the client's global safety data and ensuring all labeling was aligned with ANVISA's requirements. The solution resulted in a 100% successful application approval with full ANVISA compliance, achieved without any critical objections or delays, enabling the client to expand market access in Brazil.