🇻🇳 Regulatory Affairs Services – Vietnam
REGULATORY NEXUS GLOBAL
Vietnam Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products
REGULATORY NEXUS GLOBAL is a specialized scientific and regulatory division of Zoesoe Exports Pvt Ltd, providing professional regulatory affairs services and product registration support for Vietnam.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Vietnam regulatory framework and successfully registering their products for the Vietnam market.
Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Vietnam regulatory authority requirements.
Vietnam Regulatory Authority
Pharmaceuticals, medical devices, cosmetics and healthcare products in Vietnam are regulated by the Drug Administration of Vietnam (DAV) under the Ministry of Health Vietnam.
The authority is responsible for:
• Pharmaceutical product registration and marketing authorization
• Regulation of medicines, vaccines and biological products
• Licensing of pharmaceutical importers and distributors
• Regulation of cosmetics and healthcare products
• Monitoring product quality, safety and pharmacovigilance
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with DAV regulatory requirements.
Our Mission
To simplify Vietnam regulatory compliance and enable companies to successfully register and market their products in Vietnam through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for Vietnam
Pharmaceutical Product Registration
We prepare Vietnam-compliant pharmaceutical regulatory dossiers for submission to the Drug Administration of Vietnam.
Our services include preparation of:
• Administrative documentation
• Product formulation and composition details
• Manufacturing process documentation
• Quality control specifications and analytical methods
• Stability study reports
• Certificate of Pharmaceutical Product (CPP) documentation
• GMP documentation
• Bioequivalence documentation (where required)
All dossiers are prepared according to Vietnam regulatory guidelines and international regulatory standards.
ACTD Dossier Preparation
Vietnam follows the ASEAN Common Technical Dossier (ACTD) format for pharmaceutical product registration.
Our ACTD dossier preparation services include:
• Part I – Administrative Data and Product Information
• Part II – Quality Documentation (CMC)
• Part III – Non-Clinical Documentation
• Part IV – Clinical Documentation
Our regulatory team ensures dossiers comply with ASEAN regulatory standards and DAV submission requirements.
Pharmaceutical Registration Process in Vietnam
The general process for pharmaceutical product registration in Vietnam includes:
Appointment of a local Vietnamese importer or marketing authorization holder.
Submission of ACTD regulatory dossier and legal documentation to DAV.
Technical evaluation of product quality, safety and efficacy.
Regulatory review and compliance assessment.
Approval and issuance of marketing authorization in Vietnam.
The registration process typically takes 8–12 months depending on product category and regulatory review timeline.
Regulatory Services for Multiple Product Categories in Vietnam
Pharmaceuticals
• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• GMP compliance documentation
Nutraceuticals & Health Supplements
Vietnam has a rapidly growing market for dietary supplements and nutraceutical products.
Our services include:
• Health supplement regulatory documentation
• Ingredient regulatory compliance verification
• Label compliance documentation
• Export regulatory documentation
Herbal & Traditional Medicine Products
Traditional herbal medicines are widely used in Vietnam.
We provide regulatory documentation support including:
• Herbal product regulatory dossiers
• Traditional medicine documentation
• Ingredient safety documentation
• Export registration support
Cosmetics & Personal Care Products
Cosmetic products marketed in Vietnam must comply with ASEAN cosmetic regulatory requirements.
Our services include:
• Cosmetic Product Information File (PIF) preparation
• Ingredient regulatory compliance verification
• Cosmetic product notification documentation
• Product safety documentation
Veterinary Products
• Veterinary drug regulatory dossiers
• Product technical documentation
• Export regulatory documentation
Additional Regulatory Support
REGULATORY NEXUS GLOBAL also provides:
• Technical scientific document writing
• Product development documentation
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Export registration support for Vietnam
Vietnam Market Entry Support
Our regulatory experts assist companies seeking to enter the Vietnam pharmaceutical and healthcare market through:
• Regulatory documentation preparation
• ACTD-compliant dossier development
• DAV regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in Vietnam DAV regulatory requirements
✔ ACTD-compliant regulatory documentation
✔ Support from product development to registration
✔ Reliable scientific documentation
✔ End-to-end regulatory solutions
About REGULATORY NEXUS GLOBAL
REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd, providing global regulatory consultancy, export support and regulatory documentation services for pharmaceutical, herbal, nutraceutical and cosmetic products across international markets.