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Businesses

Approval and Licensing Agency

All : 20
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Category Consulting Items Service Details
Pharmaceuticals License applications & Registrations as an agent; Product Licensing In/Out In Country Caretaker(ICC) service as an authorized local agent
Pharmaceuticals Communication support between Clients and Agency (MFDS)
Pharmaceuticals Managing of Product Licenses (including the change) Registration(Notification) and Post-approval change
Pharmaceuticals Regulatory support in accordance with client's development plan Pre-review consulting services & Licensing strategy consulting
Pharmaceuticals Regulatory support in accordance with client's development plan Consulting of complementary processing of the application (APIs to FDFs application)
Pharmaceuticals Regulatory support in accordance with client's development plan Review on Specifications, the analysis, with the validation
Pharmaceuticals Registration of Drug Master Files (DMF) Registration(Notification) and Post-approval change
Pharmaceuticals Preparation & Review of CTD files
Pharmaceuticals Review of GMP documents and Supports of site inspection Consulting if the site is subject to on-site inspection.
Pharmaceuticals Review of GMP documents and Supports of site inspection Review of GMP documents according to Korean guidance
Pharmaceuticals Review of GMP documents and Supports of site inspection Support of Vendor audit or Prior site inspection
Pharmaceuticals Registration of Foreign manufacturing sites to Korean agency
Foods License applications & Registrations Consultation of the registration and developments of Health Funtional Foods
Foods License applications & Registrations Consultation concerning recognition of Functional ingredient and the specification
Foods License applications & Registrations Consultation of the registration for the standards of Foods and Food additives
Foods License applications & Registrations Pre-Review of the registration and Communication between Clients and Agency
Foods License applications & Registrations Application of Listing-up or the change of Foods standards
Foods Products Importing declaration Product Importing declaration on Foods, Food Additives, Functional Foods and Livestock products
Foods Products Importing declaration Compliance of Foods Label and Claims
Foods Products Importing declaration Applying of the foreign foods facilities and the change
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