Analytical Method Validation Services – Myanmar

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

We support pharmaceutical manufacturers and exporters targeting Myanmar with FDA Myanmar–compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Department of Food and Drug Administration (FDA Myanmar) queries for product registration, import authorization, and export dossiers.

Our Core Expertise – Myanmar Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the Department of Food and Drug Administration (FDA), Ministry of Health (MOH), Republic of the Union of Myanmar.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by FDA Myanmar
• 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 FDA Myanmar 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 Myanmar product registration requirements

✅ Residual Solvents Method Validation

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

Products Covered – Myanmar

✅ 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 – Myanmar

All Analytical Method Validation activities are conducted in accordance with:

• Department of Food and Drug Administration (FDA), Myanmar guidelines
• National Drug Law of Myanmar and related rules
• Myanmar pharmaceutical product registration requirements
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP principles adopted by FDA Myanmar
• Recognized pharmacopoeias (USP, BP, EP, IP)

Post-Submission Regulatory Support – Myanmar

VALIDEX provides complete Myanmar FDA query management, including:

✅ Responses to FDA Myanmar 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 FDA inspections, audits, and dossier evaluations

Why Choose VALIDEX for Myanmar?

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

Our Deliverables – Myanmar

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

Industries We Serve – Myanmar

• 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 – Myanmar

VALIDEX supports Analytical Method Validation for:

• Myanmar domestic product registration (FDA)
• Import registration and marketing authorization
• Export dossiers prepared for submission to Myanmar
• Government tenders and institutional supply registrations

Partner with VALIDEX – Myanmar

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