Our Services

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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