Support
Pharmaceuticals · Medical Devices · Combination Product
NEXJENNER SERVICE
Nexjenner Co., Ltd. supports
licensing of domestic and foreign pharmaceuticals,
medical devices, and convergence products.
Professional staff with long experience and specialized know-how will increase the efficiency of complex processes by accurately and quickly preparing licensing documents and processing tasks based on the latest regulations.
Pharmaceuticals
·New drug, Submissions, and Approvals
·NDA, IND consulting, application preparation and
MFDS representation
·Pharmaceutical development, Entire cycle of clinical
trial consulting
·Safety, Effectiveness /Criteria and Test Methods/
GMP Consulting
·Drug substance registration (DMF)
·CTD documentation
·Ministry of Food and Drug Safety prior review work
·Consulting on licensing and bridging strategy
·Training support for licensing and CTD writing methods
·Generic product approval (report)/change
·Quasi-drug product approval (report)/change
Medical devices
·Manufacturing development and licensing
consulting (medical supplies/medical equipment)
·Imported product licensing consulting
(medical supplies/medical equipment)
·Technical document review items
·Items subject to safety effectiveness review
·Approval of exploratory and confirmatory clinical trial plan
·Medical device renewal system
Combination product
·Combination product applicability
·Combination product classification
·CTD, STED documentation
·Preparation and submission/change of approval
(certification) materials