by maixaule | Feb 28, 2026 | Blog
Regulatory and Commercial Impact Analysis of ANMAT Regulations 2025–2026 1. GENERAL CONTEXT OF REGULATORY CHANGES Strategic Orientation The regulations issued by ANMAT between October 2025 and February 2026 respond to a clear strategy of modernization and...
by maixaule | Feb 26, 2026 | Blog
Introduction: A Wind of Change in Health Regulation In recent months, Argentina’s National Administration of Drugs, Foods, and Medical Technology (ANMAT) has driven a series of regulatory reforms that redefine the landscape for the import, manufacture, and...
by maixaule | Dec 29, 2025 | Blog
ANMAT Disposition 7516/2025: A Regulatory Milestone Transforming Clinical Research and Pharmacovigilance in Argentina December 1st marked a turning point in the Argentine pharmaceutical regulatory landscape. With the entry into force of ANMAT Disposition 7516/2025,...
by Analia Katriniuk | Oct 28, 2025 | Blog
Healthcare in Latin America is evolving rapidly in 2025. From digital transformation and regulatory modernization to supply chain optimization and patient-centered care, the region is embracing innovations that improve access, quality, and efficiency. While artificial...
by Analia Katriniuk | Oct 14, 2025 | Blog
When entering the Argentine market, one of the most common questions we receive from manufacturers is: “How long will it take to get ANMAT approval for my medical device?” It’s an important question. Timelines are key when planning a launch, coordinating distribution,...
by Analia Katriniuk | Sep 30, 2025 | Blog
Expanding your business into Latin America (LATAM) can be a transformative step for startups and SMEs. The region, with its growing middle class, vibrant entrepreneurial ecosystem, and diverse market opportunities, promises significant potential; but it also presents...
