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 secures OTC switch submission in Brazil with FREYR

A German multinational pharmaceutical and life sciences company sought Freyr's regulatory affairs support to switch a topical product to Over-the-Counter (OTC) status in Brazil. The key challenge was justifying the switch to ANVISA, Brazil's health authority, which required a strong safety profile and compliance with specific regulations, amid complexities in data gathering and dossier compilation.

Freyr conducted a comprehensive evaluation of global safety data and compiled a structured dossier to support the application, ensuring labeling compliance. Their team managed the submission and provided post-submission follow-up. Freyr's solution enabled a successful and timely OTC switch application, ensuring a seamless regulatory pathway for the client.