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Foreign Manufacturer KGMP
Foreign Manufacturer KGMP

MFDS Will Inspect Your Factory. We Make Sure You Pass.

The Challenge

A failed MFDS facility inspection freezes your entire Korean supply chain.

The KGMP certification process for foreign manufacturers demands Korean-language documentation, compliance with MFDS-specific GMP requirements, and readiness for an on-site inspection conducted by Korean authorities. Without local expertise, manufacturers routinely misread the requirements and enter the inspection unprepared.

Full certification management from gap assessment to approved KGMP certificate.

We handle every stage of the foreign manufacturer KGMP process — so your facility enters the inspection with complete documentation and a team trained to pass.

Documentation & Gap Assessment

We audit your existing GMP documentation against KGMP requirements, identify gaps, and prepare all Korean-language submissions required for MFDS review.

Mock Inspection & Preparation

We conduct mock inspections against MFDS protocol, train your facility team on Korean GMP expectations, and ensure every procedure and record is audit-ready before the official visit.

Certification Management

We manage all MFDS correspondence, respond to reviewer queries, and coordinate logistics throughout the certification review — until your certificate is issued.

Your Complete KGMP Certification Package

Every document and record your facility needs to achieve and maintain KGMP certification.

  • KGMP gap assessment report against current MFDS requirements
  • Korean-language GMP documentation package
  • Mock inspection report with corrective action plan
  • Official MFDS KGMP certification application
  • KGMP Certificate for your manufacturing site

Your Korean product license is only as strong as your manufacturing site certification. One lapsed KGMP certificate stops all sales.

By managing your KGMP certification program with local authority expertise, we ensure your supply chain is never disrupted by a certification gap, and your facility is prepared to pass — not just survive — the MFDS inspection.

Speak with a KGMP Certification Specialist Today

Frequently Asked Questions

Common questions about foreign manufacturer KGMP certification.