Your Partner for Success
in Japan

Yakumed is a unique service provider that is fully specialized in the Japanese Pharmaceutical, Medical Device and Gene Therapy sectors. With our multi-disciplinary team of experts we provide comprehensive and reliable services to meet your needs in Japan.

We are agile with strong focus on our clients. We cater our services to meet their unique needs.

Years combined Japan Experience
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Pharma/Biotech supported
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Drugs approved in Japan
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PMDA consultations
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Orphan Drug Designations in Japan
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Years of Japan CMC experience
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Our Services

Market Research and Japan Entry

  • A detailed analysis based on interview with Japanese investigators and desk top analysis
  • Epidemiological analysis of the disease and indication
  • Treatment paradigm and market segmentation
  • Regulatory analysis
  • Market access analysis
  • Product positioning
  • Forecast and recommendations
  • Evaluation of different entry options to Japan market
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Business Culture in Japanese Pharma and Healthcare

  • Introduction to the Japanese culture
  • Historical and Philosophical aspects and how they shaped Japanese psyche and business
  • Unique Japanese cultural considerations
  • Japanese Business Culture
  • Understand Body Language and communication
  • How to succeed in working with Japanese professionals
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Japanese Key Opinion Leaders

  • Identification and Selection of Japanese KOLs. Development of communication and engagement strategies and plans to work with KOLs.
  • Working with KOLs to understand the unmet need, the medical practice in JP and the Clinical positioning of the drug in Japan
  • How to avoid pitfalls in working with KOLs
  • How to leverage the support of KOLs for a successful PMDA consultation
  • How to leverage KOL support for an effective clinical development and commercial success
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Japanese Regulatory Strategy & PMDA consultation

  • Regulatory and Clinical Development strategy
  • Alignment of Japan regulatory strategy with global strategy
  • Evaluation of possible Regulatory pathways in Japan such as Sakigake, early conditional approval and others
  • Evaluation of suitability of non-clinical, clinical and CMC package for development and registration in Japan
  • CMC requirements and gap analysis
  • Registration strategy
  • Scientific advice with PMDA including preparation of brief book
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Orphan Drug Designation

  • We provide full support to obtain orphan drug designation in Japan
  • Robust strategy for ODD including risks and mitigation measures
  • Lead Consultations with MHLW and interaction until designation is received
  • We also support process of obtaining funding from the Japanese government
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Representation in Japan for your company

  • For companies which do not have an affiliate in Japan, representation in Japan as In-country care taker. Yakumed will represent you in communication with PMDA, MHLW and other stakeholders.
  • Support on all areas related to your clinical development, regulatory affairs, Orphan drug designation, business development and other areas.
  • Support in setting up a business affiliate in Japan as Marketing Authorization Holder (MAH)
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Partnering and Business Development

  • We have Demonstrated experience in deal-making between Europe/US and Japanese companies.
  • We provide strategic leadership and operational support to identify and select best-fit potential partners in Japan.
  • We provide full support and facilitation throughout the whole process (from initial interactions, due-diligence and negotiations) until a deal is signed between both parties.
  • We increase the chances of success by helping you understanding the market dynamics and the real value of your asset in Japan. We help you avoid gaps of communication and cultural conflicts.
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Clinical Trial Notification and CXP compliance

We provide a wide range of services related to Clinical Trial Notification (CTN):

  • Selection and recommendation of cost-effective CROs for running your clinical trial in Japan
  • Preparation, review and submission to PMDA of all documents required for CTN
  • Interaction with PMDA throughout the CTN process
  • Timely response to PMDA queries
  • Trouble shooting and regular advice and guidance for a smooth CTN

GCP compliance in Japan
Design and preparation of annual audit plan for Japan and provision of regular GCP compliance advice
Preparation for PMDA inspection and onsite management at both trial sites and sponsor sites
Support during GCP audits for trial sites
Lead and support pre-inspection site visits for PMDA inspections in Japan
Manage reporting and negotiation with PMDA and MHLW on GCP violation issues

GLP compliance
Gap analysis on GLP requirements in Japan
Support for Data reliability inspection for PMDA
Creative solutions to meet PMDA requests on GLP compliance

GMP compliance in Japan
GMP Evaluation and analysis
Plan for inspection and improvement
Education and guidance to company staff on GMP requirements and changes
GMP Document Management System
Establishment of GMP system (SOPs and standards)

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Japan NDA strategy, and execution

  • Overall JNDA Strategy including analysis and recommendations
  • Gap Analysis of global CTD and highlight parts such M1, M2 and other parts which need to be changed and adapted to meet Japanese requirements
  • Compilation of all documents necessary for J-NDA
  • Submission of NDA and support during interactions with PMDA to respond to queries and to negotiate with PMDA throughout the process
  • Lead the strategy and communication with PMDA during such intense period
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Commercial Launch Preparedness

  • Supply Chain analysis including compliance with local requirements, selection of potential CMOs, negotiation, technology transfer
  • Distribution in Japan, which includes introduction to the distribution dynamics in Japan, OTC strategy development, recommendations with regards to the suitable wholesalers and 3PL.
    Daily support to prepare RFPs, contracts, negotiations and set up process for whole commercial operations.
  • Marketing Business License (MBL) is a prerequisite before JNDA submission. We provide strategic and operational leadership to obtain MBL. This is a key requirement for a company to become a marketing authorization holder MAH) in Japan
  • Marketing strategy (conferences, website set-up, recruitment of MR ) and operations.
  • Selection of vendors for safety management post-approval
  • Organize and Management of KOL board meetings
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Crisis & Conflict Resolution in Japan

We recommend early and thorough preparation when entering Japan market, however we recognize that it is practically impossible to avoid unexpected crises throughout the development, registration and commercial journey in Japan. We have supported numerous companies going through such difficult moment. Our team of experts are in a great position to share their insights to solve the most sensitive issues in all confidentiality.

Our approach covers several layers: 1) Situation Analysis to delineate fault lines and propose possible solutions, 2) Immediate action to minimize the damage and implementation of temporary measures, 3) Mid-Long term implementation plans

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Japan Healthcare Sector Analysis

Japanese healthcare is huge, complex and constantly evolving. There are many players with conflicting interests and agendas. The wider economic, political and demographic context has a strong impact on the market dynamics. Keeping abreast of the current and anticipating upcoming potential changes is vital for pharmaceutical companies, service providers and other players interested in the Japanese healthcare sector.

Our sector analysis reports provide deep insights into the building blocks, the intricate connectivity between its different components and what lies in the horizon in terms of possible policy changes and the impact on Japanese healthcare as a whole.

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Orphan Drugs

Japan is facing a serious drug access problem. According to MHLW, there are 143 drugs that are approved in Europe and/or US but not yet in Japan. The majority of these are for orphan and paediatric indications.
MHLW has recently introduced incentives to promote the development, registration and commercialization of orphan drugs in Japan. These include measures to shorten the development time, improvements to the Japanese Orphan Drug Designation system and expected changes to pricing system.
Yakumed has a strong legacy in supporting numerous companies to introduce their orphan drugs into the Japanese market.

doctors in white coats
It was reported that cell and gene therapy (CGT) market in Japan is expected to grow to JPY 1 trillion

We are agile with strong focus on our clients. We cater our services to meet their unique needs.

Cell and Gene Therapy

It was reported that cell and gene therapy (CGT) market in Japan is expected to grow to JPY 1 trillion (USD 7 billion) in 2030 and JPY 2.5 trillion (USD 17.5 billion) in 2040. Several CGT drugs have been approved and reimbursed in Japan. Dozens are being currently developed. Yakumed has been involved in the development and approval process of several CGT drugs in Japan. There are still market-specific challenges. Yakumed can leverage its long experience and support you weather the storm ahead.

Medical Device & Digital Health

Currently, numerous medical device products, several of them are software with medical device are already approved in Japan. However, only a handful of Software as Medical Device (SaMD) are approved in Japan so far. There are a dozen of ongoing clinical trials using smart phone applications, games, and Virtual Reality tools.
Yakumed has been involved in the development and approval of medical device products and in the evaluation of SaMD and other digital health products for introduction into Japanese market.

Currently, numerous medical device products, several of them are software with medical

Mission Statement

Our mission is to ensure seamless introduction of Innovative Drugs and Medical Technologies into

“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 impact on the patients

Proud of our contribution towards the access of Japanese patients to drugs in various diseases.

Orphan Diseases

Neurological Diseases

Immunology, and other diseases

Case Studies


Integrate Japan Into Global Clinical Development



Japan Entry & NDA



Orphan Designation


Hear our clients say about us to

Hear what our incredible customers have to say!

Yakumed’s specialized expertise and experience in the rare disease/orphan space has been an enormous resource to help guide and inform our development and regulatory strategies in the Japanese marketplace. Their team is prompt and thorough in their analyses and risk assessments, and their sense of urgency to jump in as situations developed cannot be understated. And of course, having a team with proven track records in key areas /positions that is accessible as such is like having an in-house expert whenever you need one. They continue to be a great partner for me and my team and would recommend them for your company.
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. We enjoy the pleasant and professional collaboration. We highly recommend YAKUMED services.
Yakumed group has been very effective in supporting us through the authoring of the module 3 component of the Japanese NDA for our cell therapy product. They were expedient, reliable and with deep expertise in Japanese regulatory requirements. In addition, they showed flexibility in helping us address numerous adhoc strategic issues that were not necessarily related to the agreed to scope of work but were crucial to our regulatory and drug development activities in Japan. I have no reservations in recommending Yakumed as a strong reliable Regulatory Consultancy with deep expertise in Japanese drug development, and I would continue to rely on them as an excellent partner in our product development activities in Japan.
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 Agency. They have extensive contacts in both Japanese pharma and with key medical opinion leaders