We are Your Gateway for Success in Japan

Advice and support from highly respected Japanese experts

Effective Licensing and Business Development Deals with Japanese Companies

More than 100 PMDA Consultations and Orphan Drug Designations in Japan

More than 30 Drug Approvals in Japan

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Yakumed is a one stop consultancy specialising in the Japanese Pharmaceutical and Medical Device Market including Gene Therapy Consultancy in Japan. Our hand-picked world-class team of multi-disciplinary experts will support you from early stages of drug development until product approval and after product launch. We provide flexible, quick and client-focused support to meet the needs of our clients.
We combine in-depth strategy, strong communication and operational excellence to ensure your success in JAPAN PMDA.

Mission Statement

“Our mission is to ensure seamless introduction of Innovative Drugs and Medical Technologies into the Japanese Market in order to address the unmet medical needs of Japanese patients.”

Our Values

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RESPECT

We always respect our team members and clients.

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FLEXIBILITY

We focus on our clients’ needs and we adapt our strategies to meet their expectations.

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PASSION

We are passionate about bringing novel medical innovations to Japanese patients.

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DEPENDABILITY

We do what we say and we never let our clients down.

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INTEGRITY

We work with all our stakeholders at the highest ethical standards.

Our Services

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Business Development

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Regulatory Affairs

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Clinical Development

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Pricing

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Commercial

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CMC and Supply Chain

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Pharmaco Vigilance

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Japan Entry Strategy

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What our clients say

“Yakumed has been an excellent partner with our company acting as a liaison and regional expert in our efforts to identify potential pharmaceutical partnerships in Japan. I have found them professional, responsive, and very knowledgeable about the Japanese commercial market and regulatory agencies…”

Dr. Peter G. Traber, Ex-CEO of Galectin Therapeutics (Ex-CMO at GSK)

“I have worked with Yakumed over the year to assess proposed development programs and define regulatory strategy for Japan. Yakumed has been extremely professional and supportive in providing information and advice that is reliable, useful and on time.”

Head of Regulatory Strategy, Pharmaceutical company in Europe

“Our rare disease biotech company was supported by Yakumed to establish ourselves in Japan. This includes successfully setting up a legal entity, providing temporary staffing of mandatory roles, obtaining a Marketing Business License, supporting the filing of the Japanese NDA and selecting partners for manufacturing/distribution…”

Head of International Commercial of US Biotech

“Yakumed has helped us develop a sound regulatory strategy for the Japanese market, and their local knowledge has been invaluable in setting up and preparing meetings with the Japanese authorities. We can warmly recommend their services in this respect.”

CEO of a Start-up Biotech in Europe

“Excellent and reliable services on the Japanese regulatory and business development sides. I highly recommend Yakumed”

VP of a top USA Bio-Pharmaceutical Company