Simplify compliance - Accelerate access
Vietnam’s healthcare regulatory system is complex—but with the right partner, it doesn’t have to be a barrier. We provide end-to-end support for product registration and clinical trials, ensuring your healthcare solutions meet local standards efficiently and ethically. Our team navigates legal classifications, approval pathways, and documentation requirements, and can even act as your authorized local license holder.
Our service includes:
- Regulatory Strategy & Classification: Determine product classification (drug, device, supplement, etc.) and map out the appropriate approval pathway.
- Full Registration Management: Handle dossier preparation, submission, communication with authorities, and follow-up until approval is granted.
- Local License Holding: Act as your in-country license holder to enable faster and compliant market entry without setting up a local entity.
- Clinical Trial Support: Provide guidance on study design, site selection, and regulatory compliance for trials required for registration or market validation.
You need advice
Contact for Consultation
1
Regulatory Consulting
Guidance on product registration procedures and relevant legal requirements.
2
Strategy Development
Tailored business models and go-to-market strategies aligned with your objectives and market demands.
3
Market Insights & Network Connection
Provide in-depth market intelligence and support in connecting local network to accelerate market entry and growth.
Together We Can Do More
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