Rede Global de Consultoria em Assuntos Regulatórios

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 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.

A dedicated partner for medical device and IVD manufacturers, we offers deep local regulatory expertise through its offices in over 20 global locations. Services include product registration, human factors research, clinical strategy, and local in-country representation to ensure rapid, compliant market access worldwide.

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 are a consultancy specializing in FDA medical device compliance, submissions, training, and export/import services.

Regulatory Compliance Associates (RCA) is a leading global provider of regulatory and compliance expert consulting services for life science companies. The company offers expertise in regulatory affairs, assessments and audits, agency response, preparation and remediation, and new product development support for medical devices, pharmaceuticals, and compounding pharmacies.

A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.

We provide consulting services to the medical device, pharmaceutical and healthcare industry. Our services include Regulatory Affairs, Quality Management, Risk Management, Trainings and Seminars.

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.

We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.