Curia's Approach To Regulatory Compliance In Brazil

Brazil’s regulatory environment has undergone significant evolution as ANVISA continues to strengthen its oversight and align more closely with international ICH and PIC/S standards. These changes have raised expectations around quality systems, documentation, and compliance, bringing Brazil in line with other highly regulated global markets. As a result, companies seeking access to the Brazilian market must navigate more rigorous regulatory requirements, increased scrutiny, and heightened enforcement of good manufacturing practices.

Successfully meeting these expectations often requires a deep understanding of global regulatory frameworks, the ability to adapt processes to local requirements, and close coordination with experienced local partners. While the enhanced regulatory alignment supports higher quality and patient safety, it also introduces new complexity for manufacturers and developers, making regulatory readiness and compliance strategy increasingly critical for timely market entry and long-term success in Brazil.