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Pharma Regulatory Affairs Services in Vietnam
In Vietnam, getting a pharma product approved isn’t just about filling forms — it’s about knowing how the system really works. As a trusted regulatory consultant for pharmaceuticals in Vietnam, we help you move through approvals smoothly and confidently.
Vietnam
MoH Pharma Compliance and Representation Services
Working with Vietnam’s Ministry of Health involves more than just filling out forms — it requires knowing how the system works in practice. Artixio serves as your on-ground representative, handling submissions, clarifying requirements, and following up with the right departments. We stay connected with MoH officials, track each step of the process, and make sure your pharmaceutical products meet the exact compliance standards needed for market access in Vietnam.
End-to-End Drug Regulatory Support in Vietnam
Artixio provides complete guidance for pharmaceutical companies entering or expanding in Vietnam. Our role is to simplify complex regulatory steps so you can focus on your core business. We manage every stage, from initial planning to successful product launch, with a hands-on, practical approach that works in the local context.
Our pharma regulatory services include:
- Product registration with the Ministry of Health (MoH)
- Dossier preparation and submission
- Regulatory gap analysis
- Compliance review and advisory
- Pharmacovigilance system setup
- Labeling and packaging compliance checks
- Market entry strategy support
- License renewals and variations
Pharmaceutical Market Entry and Compliance Strategy in Vietnam
At Artixio, we plan the path from the very start, helping you avoid delays and unexpected costs.
We look at your product, its category, and the rules that apply. Then we match that with what the Ministry of Health expects — not just on paper, but in practice. Some approvals move faster if your documents are set up in a certain way. Some need extra local data. We make sure you know that upfront.
Our role is to keep you on the right side of the law while positioning your product for a smooth launch. You focus on building the brand; we handle the compliance grind — applications, follow-ups, translations, local representation, the lot.
Specialized Regulatory Consulting for Pharma in Vietnam
Our team works as your in-country regulatory partner, translating Vietnam’s complex rules into clear, actionable steps for faster approvals.
What gives our pharma clients in Vietnam an edge:
- Product Classification Guidance
- Regulatory Pathway Assessment
- Labeling & Packaging Compliance
- Post-Approval Variations Management
- Liaison with Vietnam MoH Authorities
Dossier Review & Submission Support
Our Regulatory Services in Vietnam
Why Trust Us For Pharma Regulatory Consulting In Vietnam?
FAQs
How long does it take to register a pharmaceutical product in Vietnam?
On average, it can take 12–18 months depending on the product type, dossier completeness, and Drug Administration of Vietnam (DAV) review timelines.
Do I need a local representative to register my pharma products in Vietnam?
Yes. The Ministry of Health requires foreign manufacturers to appoint a licensed local representative for regulatory submissions and compliance activities.
What documents are required for drug registration in Vietnam?
General requirements include a legalized Certificate of Pharmaceutical Product (CPP), GMP certificate, product dossier (CTD format), stability data, and labeling in Vietnamese.
Can variations or post-approval changes be made to a registered drug?
Yes. Variations must be submitted to the DAV for approval, with timelines and requirements depending on the change type (major or minor).
Are there different requirements for prescription vs. OTC drugs?
Yes. While both follow DAV’s registration framework, OTC drugs often have simplified data requirements compared to prescription medicines.
Industries We Serve in the Vietnam
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
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