Global RA Consultancy Network

We operate nationally, providing one-stop CRO and regulatory services with deep expertise in the NMPA (National Medical Products Administration) regulatory system. The management team has long-term working experience in the China Center for Drug Evaluation (CDE). They have successfully completed over 550 registration/clinical projects for nearly 300 customers, with a significant focus on innovative drugs and generic drug Bioequivalence (BE) studies. Services extend to Clinical Trials (Phase I-IV, PK/BE), Regulatory Affairs, Medical Affairs, and Quality Management.

Helping medical device and in-vitro diagnostic companies with CE marking, quality management systems, auditing, and global registrations.

Provides expert guidance for healthcare companies in market access, health economics, reimbursement, and business development across Europe, with a focus on Germany.

Siam Trade Development provides regulatory and market access services in Thailand, supporting foreign manufacturers throughout the full product and company lifecycle. Our services include product design support, regulatory assessments, product registration, license holding, Importer of Record (IoR), and ongoing regulatory compliance. We also assist with company incorporation, Foreign Business License and BOI applications, and import and regulatory licensing.

Established in 2020, we began as a successful distributor during the COVID-19 pandemic and expanded its scope. It operates an international sales department from its Seoul headquarters, supplying products certified under worldwide standards to both private and public sectors, including hospital and laboratory diagnostics. Furthermore, their regulatory team guides foreign manufacturers through the MFDS registration process (Class I, II, III, IV devices) and KFDA regulations, offering rapid and accurate scientific consulting solutions.

A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.

ElendiLabs specializes in medical device regulatory affairs in Hong Kong, providing comprehensive support for MDACS registration and compliance.

BCG supports medical device and in-vitro diagnostic companies in regulatory compliance, market entry, and quality enhancement in South Korea and globally.

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.