Regulatory Affairs
- Dossier review to align to local regulations
- Regulatory submission
- Regulatory strategy planning
- Regulatory Intelligence
- Regulatory support
- Basic regulatory training
- Marketing materials and artwork review
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Representative office
- Business matching to distributors
- Handle regulatory portfolio and manage commercial issues with distributors
- Function as a project or virtual assistant for ASEAN operations
Quality Management System (QMS) Setup
- Setup of Quality Management System Documentation with digital platform Vivaldi Software
- Internal audit for GDP and ISO 13485
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