Analytical Method Validation Services – Laos (Lao PDR)

Ensuring Accuracy. Compliance. Regulatory Confidence for Lao 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 Lao regulatory requirements.

We support pharmaceutical manufacturers, API suppliers, importers, Marketing Authorization Holders (MAHs), CMOs, and export-oriented companies targeting Laos with Food and Drug Department (FDD), Ministry of Health–compliant analytical validation, ICH- and ASEAN-aligned documentation, and complete post-submission handling of FDD queries for product registration, import authorization, and lifecycle management.

Our Core Expertise – Laos Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Food and Drug Department (FDD), Ministry of Health, Lao PDR, aligned with ASEAN Common Technical Dossier (ACTD/ACTR) and ICH guidelines adopted in the region.

✅ Assay Method Validation

• Potency and content determination for APIs & finished products
• Validation in accordance with ICH Q2 (R1 / R2) (ASEAN-accepted)
• Accuracy, precision, linearity, range, robustness, and specificity
• USP / BP / Ph. Eur. / IP harmonized methods with ASEAN justification

✅ Impurities Method Validation

• Related substances, degradation products, and process impurities
• Identification, qualification, and quantification of impurities
• Stability-indicating method validation as per ASEAN & FDD expectations
• Compliance with ICH Q3A / Q3B / Q3C / Q3D (regionally accepted)

✅ Dissolution Method Validation

• Immediate-release & modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition evaluation, robustness studies
• Compliance with ASEAN ACTD / FDD product registration requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C accepted by ASEAN authorities
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, precision, LOD & LOQ

Products Covered – Laos

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

Regulatory Compliance – Laos

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• ASEAN Common Technical Dossier (ACTD / ACTR)
• Food and Drug Department (FDD), Ministry of Health – Laos
• ICH Q3A / Q3B / Q3C / Q3D
• WHO-GMP (widely accepted by FDD for imports)

Post-Submission Regulatory Support – Laos

VALIDEX provides complete FDD regulatory query management, including:

✅ Responses to FDD deficiency letters
✅ Scientific justification for analytical and validation parameters
✅ Data gap assessment & corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during FDD technical reviews & inspections

Why Choose VALIDEX for Laos?

✔ Strong understanding of Lao FDD & ASEAN regulatory expectations
✔ ICH-aligned, ASEAN-focused documentation strategy
✔ Inspection-ready and audit-compliant validation reports
✔ Experience supporting import registration & MAH dossiers
✔ Fast turnaround timelines
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Laos

• Laos / ASEAN-compliant Analytical Method Validation Protocols
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• ACTD Module 2 & 3 analytical summaries
• FDD regulatory query response packages
• Method transfer, verification & re-validation documentation

Industries We Serve – Laos

• Pharmaceutical manufacturers exporting to Laos
• API suppliers
• Importers & Marketing Authorization Holders (MAHs)
• Contract Manufacturing Organizations (CMOs)
• Regional distributors
• Regulatory & dossier consulting firms

Import & Market Access Support – Laos

VALIDEX supports Analytical Method Validation for:

• FDD product registration (imported medicines)
• New registrations, renewals & variations
• ASEAN lifecycle management
• Export dossiers prepared for Laos from India, China, EU & ASEAN

Partner with VALIDEX – Laos

Achieve FDD-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Laos (Lao PDR).