Analytical Method Validation Services – Mongolia

Ensuring Accuracy. Compliance. Regulatory Confidence for Mongolia 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 Mongolian regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Mongolia with MOH / MMRA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of regulatory queries for product registration, import authorization, and export dossiers.

Our Core Expertise – Mongolia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the Ministry of Health (MOH), Mongolia, and the Medicines and Medical Devices Regulatory Authority (MMRA).

✅ Assay Method Validation

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

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of process- and degradation-related impurities
• Stability-indicating method validation aligned with MOH / MMRA 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 Mongolia product registration requirements

✅ Residual Solvents Method Validation

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

Products Covered – Mongolia

✅ 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 – Mongolia

All Analytical Method Validation activities are conducted in accordance with:

• Ministry of Health (MOH), Mongolia guidelines
• Medicines and Medical Devices Law of Mongolia
• Medicines and Medical Devices Regulatory Authority (MMRA) requirements
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP principles adopted by Mongolian authorities
• Recognized pharmacopoeias (USP, BP, EP, IP)

Post-Submission Regulatory Support – Mongolia

VALIDEX provides complete Mongolia regulatory query management, including:

✅ Responses to MOH / MMRA 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 evaluations

Why Choose VALIDEX for Mongolia?

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

Our Deliverables – Mongolia

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

Industries We Serve – Mongolia

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers and Marketing Authorization Holders (MAHs)
• Regulatory and dossier consulting firms

National & Export Support – Mongolia

VALIDEX supports Analytical Method Validation for:

• Mongolia domestic product registration (MOH / MMRA)
• Import registration and marketing authorization
• Export dossiers prepared for submission to Mongolia
• Government tenders and institutional supply registrations

Partner with VALIDEX – Mongolia

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