• We provide the patient centric support program based on the digital platform
• We can design the specialized and customized program with experience of various psp projects (SOP, Process)
• The cloud-based DKSH digital platform : A true patient-centered service that enables multi-channel and interactive communication

Category

• Pharmaceuticals (new drugs, biologics, generic drugs, biosimilars, etc.)
• Medical devices (Class I -IV), 
• In vitro diagnostic reagents (IVD)
• Cosmetics (functional, general)

Market entry

• The first step in entering the Korean market (pharmaceuticals, medical devices, cosmetics)

Strategic registration

• Application of customized strategic registration with a high understanding of regulations and various experiences

Service

• New registration
• License renewal
• Major/minor variation
• Notification change
• KGMP (on site qudit /documentation audit for manufacturing site)
• DMF (Drug Master File)
• RMP (Risk Management Plan)

•  Evaluation of the quality and system of pharmaceutical and medical device manufacturers
•  Essential process for registration and importation based on the audit of the Korea Ministry of Food and Drug Safety
•  Lead to successful on-site audit result by DKSH experts 

Pharmacovigilance reporting and inbound customer call management service based on digital platform

Responsibility and authority as a local license holder of foreign products (Pharmaceuticals, medical devices)

• Local QC test process setting and AMT (Analytic Method Transfer) implementation
• Actual simulation of local QC test before launch or first import
• Contract with local laboratory 
• The setting of SOP of import product, import management record

• Pharmaceuticals, medical devices and cosmetic products that wish to export from Korea to the Asia market
• Registration service in Asian countries

• Regulatory feasibility assessment: Diagnosis of current dossier for local submission,  Requirement check for submission or preparation
• Consultation of local Bridging study evaluation
• Local PMS consulting (collaboration with CRO partner)
• Advertisement review for pharmaceuticals, medical devices, and cosmetics under local regulation

Providing reimbursement service (dosser preparation, negotiation, Pharmaco Econonic assessment reprot) for drug price and treatment materials of Medical Device in collaboration with proven partners