Biologics Consulting Group (BCG Inc.)
SUCCESS, TOGETHER
Headquarters: South Korea
About Biologics Consulting Group (BCG Inc.)
BCG is a leading consulting company in South Korea specializing in medical devices and in-vitro diagnostic devices. Composed of professional consultants with extensive practical experience in domestic and foreign corporations, BCG has deep understanding and expertise in medical device regulations including MFDS, ISO 13485, and U.S. FDA's 21 CFR. The company provides tailored solutions for regulatory compliance, helping manufacturers and importers meet requirements, obtain approvals, and compete in the global market.
Why Choose Biologics Consulting Group (BCG Inc.)?
Expert team with extensive practical experience in medical device regulations, especially in South Korea and international markets.
Specialized consulting for medical devices and in vitro diagnostics (IVD), helping companies navigate complex regulatory challenges.
Comprehensive support for market entry in South Korea, including registration, licensing, and compliance.
Assistance with Quality Management System (QMS) setup, KGMP certification, and audit preparation.
Reliable services for manufacturing/import licenses, product approvals, and health insurance reimbursement.
Up-to-date regulatory trends and industry insights provided through newsletters and news updates.
Proven track record in helping clients achieve successful global and Korean market access.
Collaborative approach focused on client growth, business success, and overcoming regulatory hurdles.
Specializations
10+ Services
Global Presence
1 Offices
Languages
3 Languages
Markets
1 Regions