xCARE: Expanding Medical Support with Over 1,000 Registered Experts Worldwide

xCARE: Revolutionizing Medical Development Support

In a significant milestone, xCARE, a company specializing in the development support of pharmaceuticals and medical devices, has surpassed 1,000 registered experts on its medical professional platform. Established to foster collaboration between various stakeholders in the healthcare industry, xCARE is making strides both domestically and internationally.

Expert Platform: More Than 1,000 Experts Registered

As of 2025, xCARE has successfully registered over 1,000 experts within its platform, with contributions from experts based both in Japan and overseas. Each category boasts over 500 specialists, covering a broad spectrum of fields such as clinical trials, regulatory affairs, manufacturing, quality assurance, and intellectual property. The strength of xCARE lies in its diverse expertise, especially in areas related to pharmaceuticals such as clinical trials, CMC (Chemistry, Manufacturing and Controls), and regulatory affairs. The organization also excels in supporting medical devices, particularly in areas of insurance reimbursement and quality management systems (QMS). By forming teams with different specializations, xCARE can provide seamless support from planning to development and regulatory approval.

Over 300 Successful Project Supports

The number of projects supported by xCARE has been steadily increasing, surpassing 300 cumulative projects. These initiatives range from startups emerging from universities in Japan to collaborations with major pharmaceutical companies and medical device manufacturers. Notably, xCARE has partnered with global enterprises in North America, Europe, and Asia, enhancing its support network.

Example of Project Collaborations

Klingl Pharma Inc.

- Support Overview: As part of IND application efforts in the U.S., xCARE offers comprehensive services, including gap analysis, CRO management, KOL collaboration, and FDA strategy development. With xCARE's assistance, a project manager capable of overseeing overseas initiatives was recruited, establishing a long-term development framework in the United States.
- Expert Involvement: An executive with over 30 years of U.S.-based pharmaceutical expertise from Astellas Pharma significantly contributed to this project.
- CEO Remarks: “xCARE made optimal suggestions suited to Klingl Pharma by understanding the environment of biotech ventures. Their prompt local decision-making greatly advanced our projects.”

Heart Lab Co., Ltd.

- Support Overview: Within six months, xCARE successfully navigated regulatory pathways for medical device approval, including the creation of QMS and documentation for regulatory submissions. Their involvement allowed this early-stage startup to efficiently hire full-time employees.
- Expert Involvement: Experts with extensive backgrounds in QMS construction, regulatory approval of artificial heart-lung machines, CT, and MRI systems, contributed significantly to this project.
- CEO Remarks: “Our internal team worked harmoniously with expert consultants. Having hands-on partners like xCARE gives startups peace of mind while progressing.”

Current Issues in Pharmaceutical and Medical Device Development

While Japan maintains a reputation for unparalleled technological prowess, significant obstacles persist in commercializing research outcomes. Particularly, startups emerging from academic institutions and smaller medical device companies often lack personnel with the requisite expertise in regulatory, clinical, intellectual property, and quality management domains. Consequently, valuable technologies that could benefit society frequently remain untapped.

Looking Ahead: Expanding Global Platforms

xCARE aims to create a new mechanism for connecting with experts exactly when needed, inspiring the development of numerous healthcare products. Their goal is to expand this expert platform globally, starting with support for Japanese companies seeking to enter the U.S. market, as well as aiding European and American firms to pivot into Asia.