ArkMS and M-With Form Business Alliance to Expand CRO Business and Enhance Drug Safety Support
ArkMS, a subsidiary of Alfresa Group, has entered into a business alliance with M-With to strengthen support services related to the safety of pharmaceuticals and medical devices, responding to increasing demands for PMS and medical writing.
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- 📰 Published: March 31, 2026 at 22:00
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ArkMS Corporation (Toshima-ku, Tokyo; President: Hitoshi Mizuo; hereinafter "ArkMS"), a subsidiary of Alfresa Group, has entered into a basic business alliance agreement with M-With Co., Ltd. (Osaka-shi, Osaka; President: Shunichi Sugimoto; hereinafter "M-With") regarding safety-related support services for pharmaceuticals and medical devices and related sales activities.
### 1. Background and Objectives
A notification issued by the Ministry of Health, Labour and Welfare (MHLW) in July 2024 states that if no specific issues arise during the approval process or post-marketing, post-marketing efficacy may be evaluated through literature analysis instead of traditional post-marketing surveys. Conversely, when the number of clinical trial cases is limited, the importance of Post-Marketing Surveillance (PMS) is high, making continuous safety evaluation and the promotion of proper use essential. Furthermore, as safety-related support services become more sophisticated, there is a growing need for planning and consulting beyond routine surveys, as well as the creation of Risk Management Plan (RMP) materials and medical writing.
The Alfresa Group positions its Total Supply Chain Service (TSCS)—which provides integrated services from drug introduction/development and manufacturing to logistics, sales, PMS, and the "last mile"—as a core business strategy. It offers the "PATH-Solution" (trademark pending) platform to comprehensively support overseas emerging bio-pharmaceutical companies entering the Japanese market. Within TSCS, ArkMS functions as a Contract Research Organization (CRO), providing high-quality, comprehensive solutions from clinical trials and investigator-initiated trials to post-marketing surveys in the fields of pharmaceuticals, medical devices, and regenerative medicine.
Through this business alliance, both companies will bring together their specialized personnel with experience in pharmaceutical companies to further strengthen their systems in PMS, Pharmacovigilance (PV), and medical writing within the Good Vigilance Practice (GVP) and Good Post-Marketing Study Practice (GPSP) domains. By sharing their sales networks, they aim to improve quality and proposal capabilities while expanding opportunities for new business deals. These efforts will further enhance ArkMS’s CRO business and the functions of the Alfresa Group’s TSCS.
### Reference Terms:
* PMS (Post-Marketing Surveillance): Surveys conducted after a product is marketed to ensure quality, efficacy, and safety.
* RMP (Risk Management Plan): A plan to manage the risks associated with a pharmaceutical product.
* Medical Writing: Creating specialized medical/pharmaceutical documents like clinical study reports and approval application materials with scientific validity.
* GVP: Good Vigilance Practice.
* GPSP: Good Post-Marketing Study Practice.
### 1. Background and Objectives
A notification issued by the Ministry of Health, Labour and Welfare (MHLW) in July 2024 states that if no specific issues arise during the approval process or post-marketing, post-marketing efficacy may be evaluated through literature analysis instead of traditional post-marketing surveys. Conversely, when the number of clinical trial cases is limited, the importance of Post-Marketing Surveillance (PMS) is high, making continuous safety evaluation and the promotion of proper use essential. Furthermore, as safety-related support services become more sophisticated, there is a growing need for planning and consulting beyond routine surveys, as well as the creation of Risk Management Plan (RMP) materials and medical writing.
The Alfresa Group positions its Total Supply Chain Service (TSCS)—which provides integrated services from drug introduction/development and manufacturing to logistics, sales, PMS, and the "last mile"—as a core business strategy. It offers the "PATH-Solution" (trademark pending) platform to comprehensively support overseas emerging bio-pharmaceutical companies entering the Japanese market. Within TSCS, ArkMS functions as a Contract Research Organization (CRO), providing high-quality, comprehensive solutions from clinical trials and investigator-initiated trials to post-marketing surveys in the fields of pharmaceuticals, medical devices, and regenerative medicine.
Through this business alliance, both companies will bring together their specialized personnel with experience in pharmaceutical companies to further strengthen their systems in PMS, Pharmacovigilance (PV), and medical writing within the Good Vigilance Practice (GVP) and Good Post-Marketing Study Practice (GPSP) domains. By sharing their sales networks, they aim to improve quality and proposal capabilities while expanding opportunities for new business deals. These efforts will further enhance ArkMS’s CRO business and the functions of the Alfresa Group’s TSCS.
### Reference Terms:
* PMS (Post-Marketing Surveillance): Surveys conducted after a product is marketed to ensure quality, efficacy, and safety.
* RMP (Risk Management Plan): A plan to manage the risks associated with a pharmaceutical product.
* Medical Writing: Creating specialized medical/pharmaceutical documents like clinical study reports and approval application materials with scientific validity.
* GVP: Good Vigilance Practice.
* GPSP: Good Post-Marketing Study Practice.