Analytical Method Validation Services – Cambodia

Ensuring Accuracy. Compliance. Regulatory Confidence for Cambodia 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 Cambodian regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Cambodia with DDP-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Department of Drugs and Food (DDF) / Ministry of Health queries for product registration, import authorization, and export dossiers.

Our Core Expertise – Cambodia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the Department of Drugs and Food (DDF), Ministry of Health, Kingdom of Cambodia.

✅ Assay Method Validation

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

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of process- and degradation-related impurities
• Stability-indicating method validation aligned with DDF Cambodia and ICH expectations

✅ Dissolution Method Validation

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

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C accepted by Cambodian authorities
• Class I, II, and III residual solvents
• Limit justification, system suitability, accuracy, and precision

Products Covered – Cambodia

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

Regulatory Compliance – Cambodia

All Analytical Method Validation activities are conducted in accordance with:

• Department of Drugs and Food (DDF), Cambodia guidelines
• Law on the Management of Pharmaceuticals (Cambodia)
• Prakas and Sub-Decree on Pharmaceutical Product Registration
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP principles adopted by Cambodian authorities
• Recognized pharmacopoeias (IP, USP, BP, EP)

Post-Submission Regulatory Support – Cambodia

VALIDEX provides complete Cambodia regulatory query management, including:

✅ Responses to DDF / MOH deficiency letters and review comments
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and validation reports
✅ Technical support during regulatory inspections, audits, and dossier reviews

Why Choose VALIDEX for Cambodia?

✔ Strong understanding of Cambodian pharmaceutical regulatory expectations
✔ ICH-aligned, Cambodia-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Efficient timelines for Cambodia registration projects
✔ Strict confidentiality and data integrity compliance
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Cambodia

• Analytical Method Validation Protocols (Cambodia-compliant)
• Validation Reports for:
– Assay
– Impurities
– Dissolution
– Residual Solvents
• Dossier summaries for Cambodia DDF submissions
• Regulatory query response packages
• Method transfer, verification, and analytical bridging documentation

Industries We Serve – Cambodia

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Export-oriented pharmaceutical units
• Regulatory and dossier consulting firms

National & Export Support – Cambodia

VALIDEX supports Analytical Method Validation for:

• Cambodia domestic product registration (DDF / MOH)
• Import registration and marketing authorization
• Export dossiers prepared for submission to Cambodia
• WHO-tender and government supply registrations

Partner with VALIDEX – Cambodia

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