Client Profile
A Singapore-based medical device startup with FDA-cleared products seeking PMDA approval for the Japanese market.
The Challenge
Japan's medical device regulatory framework (PMDA) is one of the most complex globally. The startup had no Japanese-language documentation, no local regulatory affairs team, and no relationships with Japanese distributors.
Our Approach
Nirji assembled a local regulatory affairs team, managed the PMDA pre-submission consultation, coordinated clinical data translation and localisation, and identified 5 potential distribution partners through our Japanese network.
Solution Delivered
Secured PMDA approval within 14 months (vs. 24-month industry average), signed an exclusive distribution agreement with a top-3 Japanese medical device distributor, and projected $8M in Year-2 Japan revenue.
Measurable Outcomes
14 months
PMDA Approval Timeline
24 months
Industry Average
$8M
Projected Year-2 Revenue
5
Distribution Partners Screened
"Japan was our most challenging market entry. Nirji's regulatory expertise and local relationships made it possible."
Services Used in This Engagement
This case study involved the following Nirji capabilities.
How This Connects to Our Broader Practice
This engagement exemplifies how Nirji Ventures integrates multiple capabilities to deliver end-to-end results. Companies facing similar challenges often benefit from our investment banking practice for capital transactions, business transformation consulting for operational improvements, and financial advisory for structuring and governance.
For companies expanding internationally, our global expansion advisory provides market entry support across 30+ countries. Early-stage ventures can explore our startup consulting practice for strategic guidance from pre-seed through Series B.
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