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JAPAN:
Authorized Agent / In-Country Care Taker
Drugs / Devices
- Product Life Cycle Management
- Clinical Studies Consulting
- Regulatory Strategy Consulting and Liaison
- Compilation, preparation and Submission of Regulatory Documents and Reports
- Drugs – Branded / Generics
- Biologics
- Devices
- Preparation of documents on product's manufacturing and quality control
- Liaison with PMDA
- CTD / eCTD
- Annual Report
- Query Management
- Risk Management & PSUR writing
- Medical Communication, Training, and 24/7 Call Center
- Establishment registration and Drug / Device Listing
Local presence to tackle local cultural and language differences (Language translation support)
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