Business Info
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 |