Rede Global de Consultoria em Assuntos Regulatórios

A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.

We assist medical device companies with the medical device registration and approval in Japan. Regulatory consulting services and DMAH services for foreign manufacturers to enter Japanese market.

We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.

We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.

Since 1921, we have been developing and manufacturing high-quality, "MADE IN JAPAN" medical equipment, contributing to safer medical operations globally. Beyond their product manufacturing, they hold the Type I Marketing Authorization Holder (MAH) license in Japan, allowing them to provide comprehensive regulatory services, including DMAH services, approval applications, and post-marketing safety management under the PMD Act for non-Japanese manufacturers.

We deliver to its client’s industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. We work with more than 850 companies in the MedTech industry annually on more than 1700 projects, demonstrating its global leadership. We are a leading medical device, diagnostics, and biologics CRO and advisory firm integrating regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics.

A boutique consulting firm specializing in Asian medical and pharmaceutical regulatory affairs and business development. We provide comprehensive, on-the-ground support for market entry, registration, quality compliance, and local agent representation across 12 Asian markets.