Analytical Method Validation Services – Thailand

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

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

Our Core Expertise – Thailand Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Thai Food and Drug Administration (Thai FDA) under the Ministry of Public Health (MoPH).

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by Thai FDA
• 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 Thai FDA & ICH 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 Thai FDA product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Thailand

✅ 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 – Thailand

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Thai FDA Drug Registration Guidelines
• Drug Act B.E. 2510 (1967) and subsequent amendments
• ASEAN Common Technical Dossier (ACTD / ACTR)
• WHO-GMP Guidelines (recognized by Thai FDA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Thailand

VALIDEX provides complete Thai FDA query management, including:

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

Why Choose VALIDEX for Thailand?

✔ Strong understanding of Thai FDA & 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 – Thailand

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

Industries We Serve in Thailand

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

National & Export Support – Thailand

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Thailand

Achieve Thai FDA–ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Thailand.