Regulatory & Consulting Solutions for Japan

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Access regulatory strategy consulting and In-Country Clinical Caretaker (ICCC) services that enable optimal product development of novel biopharmaceutical products in Japan.

Develop a Sound Regulatory Strategy in Japan

We invest in your submission’s success with our team of experienced regulatory leaders. Your submissions are backed by broad experience and specialized services in a wide range of therapeutic areas and indications.

  • Access insights to navigate Japan’s evolving regulatory environment
  • Achieve near-simultaneous global regulatory approval of your product
  • Get advice on obtaining SAKIGAKE designation, expedited approval for regenerative medicines or orphan drug designation

Enable the Optimal Development of Novel Biopharmaceutical Products for Japan

After decades of continuous harmonization of medical practices and with the successful initiative of the Ministry of Health, Labor and Welfare (MHLW) in Japan to create a regulatory framework aligned with the U.S. and EU, Japan has become well integrated into the global drug development landscape. 

This steady regulatory reform that made Japan’s integration into U.S. and EU-led drug development programs possible, MHLW and Pharmaceuticals and Medical Devices Agency (PMDA) have now brought forth dynamic initiatives aimed at establishing Japan as a global leader in the development of breakthrough drugs addressing high, unmet medical needs. 

Leveraging its multi-disciplinary team of drug development experts, we can not only successfully integrate Japan into global drug development programs but also work with clients to navigate these novel regulatory pathways such as SAKIGAKE, advance approval of regenerative medicines or support a product’s designation as an orphan drug. 

Let us help you design development programs and increase your chances of success.

Assess Your Commercial Potential With a Product Development and Regulatory Strategy

Access strategic, medical and scientific consulting services as we help you enhance your product’s commercial potential and navigate the most optimal Japanese product development route. We can comprehensively plan, initiate and manage the implementation of all Japanese and Asian clinical trials necessary for Japanese and Pan Asian product approval, from Phase I through Phase IV. We can also serve as a Clinical Trial In-Country Caretaker (CT-ICC) that jointly undertakes the legal, regulatory and operational obligations of you as a Foreign Sponsor.  

From preparing your development plan to supporting your formal consultations with the PMDA, we can support you as an official Marketing Authorization Holder (MAH) to file and maintain official submissions to the MHLW on your behalf. 

Go Beyond Japan

Together, we can help bring your product into Japan and incorporate your parallel regulatory strategies for a global market release. As part of the Global Regulatory Affairs & Product Development Consulting team, we offer support in North America, the UK, Europe and APAC.  

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