Regulatory And Research Services for Vietnam
🇻🇳 Regulatory and Research Services for Vietnam – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research services for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Vietnam market.
Our services ensure full compliance with the Vietnam Drug Administration (DAV) under the Ministry of Health (MOH), as well as WHO and ICH guidelines.
📘 Regulatory Services for Vietnam
Regulatory & Product Registration Support – Vietnam
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with DAV Vietnam, ensuring smooth market access and full regulatory compliance.
📘 Product Registration Services
• Preparation and submission of registration dossiers for prescription (Rx) and OTC products.
• Registration support for Herbal, Traditional, Nutraceutical, Veterinary, and Cosmetic products.
• Guidance on labeling, packaging, and product information leaflets according to DAV Vietnam regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Vietnam.
• Support in preparing quality, safety, and stability documentation in line with DAV Vietnam and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in DAV-approved CROs.
• Preparation of BE study protocols and reports according to WHO and DAV Vietnam requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods in compliance with ICH Q2(R2).
• Preparation of AMV documentation for regulatory submission and routine QC.
🧾 Regulatory Consultancy & Compliance
• Strategic regulatory guidance for entry into the Vietnam market.
• Assistance with import/export licensing, DAV Vietnam inspections, renewals, and post-approval compliance.
• Continuous updates on DAV Vietnam regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Vietnam
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with DAV Vietnam and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Vietnam’s tropical climate conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per DAV Vietnam requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to DAV Vietnam.
• Inclusion of formulation, manufacturing, QC, and stability data.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols, investigator brochures, and final reports.
• Toxicology studies according to OECD and WHO guidelines for DAV Vietnam submission.
🌏 Why Choose Us for the Vietnam Market
• Experienced Regulatory Experts – Skilled in DAV Vietnam, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across ASEAN markets.
• Efficient Documentation – Streamlined processes for faster regulatory approvals.
• Custom Strategies – Tailored per product type, regulatory pathway, and market requirements.
📘 Regulatory & Dossier Documentation
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⚗️ Bioequivalence & Analytical Studies
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🧪 Technology Transfer & Safety
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