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Setting Up a MAH in Japan: 5 Hard Truths (That Turned Out to Be Manageable)

What we learned by doing it ourselves — and why it’s only possible with local expertise “We Thought It Would Be Impossible. It Wasn’t — But Only Because We Knew the Terrain.” When we set out to establish a fully licensed MAH (Marketing Authorization Holder) in Japan — from scratch Read more

By md, 8 monthsJuly 17, 2025 ago
Regulatory

Navigating the Japanese Pharmaceutical Market: A Strategic Guide for Foreign Companies

Expanding into the Japanese pharmaceutical market presents a wealth of opportunities for foreign companies, but it also comes with unique challenges. Regulatory complexities, language barriers, and the need for local expertise make market entry a daunting process. We have recently obtained MAH license for a licent, and would like to Read more

By md, 12 monthsMarch 18, 2025 ago

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