Analytical Method Validation Services – Vietnam

Ensuring Accuracy. Compliance. Regulatory Confidence for Vietnam Regulatory Submissions

VALIDEX, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Analytical Method Validation (AMV) services for Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Finished Products, fully compliant with Vietnam regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Vietnam with DAV-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Drug Administration of Vietnam (DAV) queries for product registration, marketing authorization, manufacturing/import licensing, and export dossiers.

Our Core Expertise – Vietnam Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Drug Administration of Vietnam (DAV) under the Ministry of Health (MoH), Socialist Republic of Vietnam.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by DAV Vietnam
• Accuracy, precision, linearity, robustness, and specificity
• USP / BP / EP / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with DAV, ICH, and ASEAN expectations
• Compliance with ICH Q3A / Q3B and pharmacopoeial impurity limits

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with DAV product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C adopted by DAV Vietnam
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, and precision

Products Covered – Vietnam

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders, sachets)
✅ Injectable formulations (sterile & non-sterile)
✅ Semi-solid & liquid dosage forms
✅ Modified-release and controlled-release products

Regulatory Compliance – Vietnam

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• DAV Drug Registration Guidelines & Circulars
• Law on Pharmacy No. 105/2016/QH13
• ASEAN Common Technical Dossier (ACTD / ACTR)
• WHO-GMP Guidelines (recognized by DAV)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Vietnam

VALIDEX provides complete DAV query management, including:

✅ Responses to DAV screening and technical evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during DAV inspections, audits, and dossier evaluations

Why Choose VALIDEX for Vietnam?

✔ Strong understanding of DAV & ASEAN regulatory expectations
✔ ICH-aligned, ACTD-compliant documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Vietnam

• Analytical Method Validation Protocols (DAV-compliant)
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• ACTD / CTD summary documents for DAV submissions
• Regulatory query response packages
• Method transfer, verification, and re-validation documentation

Industries We Serve in Vietnam

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic and branded formulation companies
• Contract Manufacturing Organizations (CMOs)
• Marketing Authorization Holders (MAHs)
• Importers, distributors, and regulatory consulting firms

National & Export Support – Vietnam

VALIDEX supports Analytical Method Validation for:

• Vietnam domestic product registration (DAV)
• Manufacturing and import license applications
• Export dossiers prepared for DAV & ASEAN-regulated markets

Partner with VALIDEX – Vietnam

Achieve DAV-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Vietnam.