New creative & New challenge

with Korea Medical Industry Institute of Goods Management Procedure



Business


01. GMP
- GMP interpretation Assistance, GMP Audit Assistance
- Clean Room Turn-key Solution _ Design, Construction and Installationsss
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02. STED
- Smart Auto – Formatting Program : To minimize not only the consulting fees but the times spent for the supplementation of the medical device technical documents
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03. Label Review
- Provide U.S.A., EU, and China Label Registration Compliance Assistant
- Please refer to our sample
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04. Regulatory Affairs
- Provides FDA, CFDA and CE Registration Compliance Assistant _ Food, Medical Device, Drug and Cosmetics
- Registration Updates, Mock Inspection, Prior Notice, Detention Assistant, Pre-Shipment Review
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• HACCP : K-GMP provided the guidelines to acquire the HACCP *HACCP is a systematic preventive approach to food safety from biological , chemical, and physical hazards in production processes

• GMP : According to amendment of Medical Device Act, K-GMP provided the detailed guidelines or materials for GMP audit

• Medical device Doc. : We figure out quality management system based on their industry specifications and help build up a new QMS as well as ‘Quality Manual’, ‘Internal Procedures’, and ‘Standard Operating Procedure, SOP’

• CTD : We assist to write CTD for quality management . *The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States

• ISO : K-GMP assists to acquire ISO(International standard Organization) certification
   ISO9001 : Quality management systems _ Requirements
   ISO22716 : Guidelines on Good Manufacturing Practices, GMP (Cosmetic)
   ISO 13485 : specifies requirements for a quality management system (Medical Device)

• RA&QC : K-GMP helps manufacturers sell their products on the market by taking care of their regulatory affairs (FDA, EU and CFDA)
   US, FDA - Registrar Corp.
   EU, CE - CE way.
   China, CFDA – 北京采瑞医药科技有限公司