EPS Corporation
Offering Comprehensive Lifecycle Management of Medical Innovations

As a leading clinical research organization (CRO) in Japan, EPS Corporation prides itself on an expansive portfolio that spans the entire gamut of product development and clinical research, from initial planning to post-marketing endeavors. The organization’s strength lies in its robust team of approximately 3,300 staff members equipped with extensive expertise and a wealth of experience. This enables EPS to address unmet medical needs and proactively tackle challenges across multiple therapeutic domains, with a primary focus on oncology and CNS fields.

EPS offers comprehensive support for regenerative medicine, an area where its prowess is widely acknowledged. Its involvement covers an extensive spectrum, encompassing services that range from early-stage planning and regulatory consultations to complete outsourcing of clinical trials, assistance with drug approval applications, and ongoing Post Marketing Surveillance (PMS) support.

“We stand among a select few CROs in Japan capable of offering holistic support throughout the lifecycle of regenerative medicine products,” says Takehisa Yamada, president and representative director at EPS Corporation.

Navigating the landscape of regenerative medicine poses distinct challenges, especially concerning evolving regulatory frameworks and the dynamic nature of the field. EPS Corporation is adept at addressing these challenges, particularly those related to unique Japanese regulations. The company’s extensive experience in dealing with the Pharmaceuticals and Medical Devices Agency (PMDA) enables it to guide clients effectively through the intricacies of compliance and regulatory adherence. EPS excels in handling operational issues specific to regenerative medicine, such as product logistics and negotiations with investigational sites.

EPS takes a methodical step-by-step approach to understand the PMDA’s perspectives. This involves close collaboration with clients to devise development strategies that align with both regulatory requirements and clients’ risk tolerance levels. The high satisfaction levels expressed by clients’ post-project completion, leading to repeat orders and expansion into new therapeutic areas, serve as a testament to EPS’ effectiveness.

Regulatory compliance is pivotal in global drug development, and EPS shines in this arena. With Japan hosting some of the strictest regulations for regenerative medicine, its expertise in meeting these standards essentially paves the way for compliance with regulations in other regions, significantly facilitating the global expansion of drug development initiatives.

We stand among a select few CROs in Japan capable of offering holistic support throughout the lifecycle of regenerative medicine products

EPS’ success stories are best exemplified through the transformational impact of regenerative medicine products in enhancing patients’ lives. These groundbreaking products have been instrumental in areas where conventional treatments fell short, such as cardiovascular, skin, nerve, and cartilage regeneration, alongside treatments for malignant tumors. By aiding in the development of therapies that restore damaged tissues and organ functions, EPS has played a pivotal role in improving the quality of life for patients across various therapeutic domains. While numerous CROs have surfaced, EPS remains distinguished due to its extensive track record, specialized expertise, and its capability to prepare Common Technical Documents (CTDs) for regenerative medical products, particularly in the critical Chemistry, Manufacturing, and Controls (CMC) aspect.

With a focus on new modalities and a flexible approach to regulatory requirements, EPS continues to spearhead advancements in the dynamic landscape of pharmaceuticals, medical devices, and regenerative medicine products. The ultimate goal is to ensure a brighter future for patient care and treatment innovation.