Global Regulatory Affairs Consulting

K-GMP provides FDA, CFDA, CE Registration Compliance Assistant for Companies in the Food, Medical Device, Drug and Cosmetics Industries



CEO's Message




Korea Medical Industry Institute of Goods Management Procedure (K-GMP) aims to provide accurate and prompt advice on MFDS in regards to Domestic and imported medical devices and to offer objective and reliable information about health and medical technology through a colossal amount of database.

In addition, based on valuable experience and competence, K-GMP wishes to serve as the most reliable assistant in helping you to become the forefront competitor in a market with strengthening regulations according to countries and dynamic conditions. We offer you solutions for your business with our deep expertise in regulations and reimbursement system necessary for manufacturing, importing and sales of medical device, food, cosmetic and drug.

Also, we will always try to achieve what we promise with our clients as a representing example of Korea female-owned business.

Many thanks.


CEO
Christine Kim

Mission & Vision




Customer' Happiness
★ Customer-focused & Customized Services
★ Reasonable Price
★ Maximize satisfaction
★ Foster together with customers

Human - being
★ Respect each one of employees as unique individuals
★ K-GMP fosters all employees- talents

Value Creation
★ Integrity and safety assurance through reinforcing internal stability
★ Lead all employees into a better future
★ Consistent and trust-worthy mindset
★ Be challengeable and creative
★ Ethical and innovative management

K-GMP would like to provide the best services for customers and contributes to the human society through talents and expertise we possess based on services, government support, education & training, consulting, GMP interpretation businesses in the medical care industry.

History




2012
- Foundation of K-GMP Co., Ltd

2013
- Taiwan Gale Med GMP Audit Interpretation
- Germany Surgiceye Audit GMP Interpretation
- France Tornier GMP Audit Interpretation
- Korea Agro_Fisheries & Food Trade Corp. U.S. FDA Conference
- MOU with Registrar Corp.
- Singapore Health Status GMP Audit Interpretation
- Domestic Medical Device Hospital Facility Exhibition
- Italy K-Laser GMP Audit Interpretation
- Certificate of Patent Application (Business Name)
- BMCC Marketing Strategy Conference
- Finland INION GMP Audit Interpretation

2014
- SPC Paris croissant O-water has been registered in FDA
- MOU with CE.way & 北京采瑞医药科技有限公司
- KOREA EUNDAN Solar- C has been registered in CFDA
- The Truemetic ISO22716 CE Audit Interpretation
- Chunho FOOD FDA Audit Interpretation
- SEOUL FOOD(2014), Global food Standard Conferenc
- SOLCO BIO MEDICAL FDA 510K submitted
- FDA/CFDA Cosmetics & Food Approval Seminar
- Certificate of Women Enterprise

K-GMP was established on Nov 1,2012 to facilitate the quality management system and regulatory affairs for medical devices manufacturing/exporting companies, and to become an professional education institute for GMP audit as GMP audit agent.

We have provided our expertise for Food, Drugs, Cosmetics and Medical device companies about FDA compliance since we had MOU with U.S biggest FDA Agent, Registrar Corp.

Organization





★ GMP Audit Assistance Dept.
WORK
- Laboratory pre-auditing
- System training for ISO
- Directives introduction and testing process demonstration
- Correlation sample testing and correction suggestion
- Laboratory management system and technical audits
- GMP Interpreter Service


★ RA/QC Dispatch Work Dept.
WORK
- Approval of manufacturing(importing) business
- Approval of any change in manufacturing business
- Approval of Manufacturing(Importing)
- Summa of Technical Documentation (STED)


★ MFDS Approval & Education Dept.
WORK
- Internal application development and maintenance
- Web page maintenance
- Computational support


★ R&D Dept.
WORK
- Internal application development and maintenance
- Web page maintenance
- Computational support


★ GCD(Global Collaboration Development Dept.)
WORK
- Domestic/International approval related Consulting
1. Domestic: MFDS, GMP, STED
2. International: FDA, CFDA, CE

Location

How to find us?_K-GMP is always waiting for you.

Directions

★ Subway : Line No.4 Seonbawi Station exit 2
★ Bus : 11-1, 11-2, 11-5, 103, 441, 502, 540, 777, 4435, 7000, 7001, 7007-1, 7770, 7780, 9200, M6405
★ Flight : About 50~60min. From Incheon Airport


Other ways to reach us

You can also get in touch.

E-MAIL k-gmp@kgmp.com
BLOG blog.naver.com/kgmpcom
PHONE +82 31-548-0055
ADDRESS
#13813
10, Yangjimaeul 4-ro
Gwacheon-si
Gyeonggi-do
Republic of Korea