Consultants

ASEAN's first ISO-certified regulatory affairs consultancy dedicated to medical devices and IVDs (est. 2013). 8 offices across Singapore, Malaysia, Indonesia, Thailand, Philippines, Vietnam, and Cambodia. Provides device registration, authorized representation (AR), and post-market compliance. AR model allows manufacturers to appoint multiple distributors independently.

Global regulatory affairs firm with South Korea expertise. Helps medical device firms navigate MFDS approvals, registration, testing requirements, and regulatory liaison support.

Austin-based consulting firm providing expedited registration, independent license holding, and commercial support across 16 Asian markets including Korea, Japan, China, India, and all major ASEAN countries.

US-based CRO and market access consulting firm specializing in Latin American medical device market entry. Core services: INVIMA regulatory registration in Colombia, first-in-human clinical trials (40% faster, 30% cheaper than US/EU), and local distributor matchmaking.

Korean medical device and IVD consulting firm assisting manufacturers and importers with MFDS regulatory requirements, KGMP compliance, and market entry strategy.

UK Notified Body's Korean operation. Offers CE MDR, ISO 13485, and UKCA marking services with global recognition.