Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Myanmar

Myanmar FDA–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd

DMF Direct provides comprehensive Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for Myanmar’s regulatory framework.

Our DMF services are designed to meet the requirements of the Food and Drug Administration (FDA), Ministry of Health and Sports, Myanmar and comply with:

• National Drug Law of Myanmar

• Myanmar FDA Registration & GMP Regulations

• ASEAN GMP & ASEAN CTD (ACTD)

• ICH Guidelines

• ACTD / CTD-based submissions used for:

• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & product registration dossiers
• Export-oriented regulatory filings

We specialize in the preparation and maintenance of both:

1. Open Part (Applicant’s Part)

2. Closed Part (Restricted / Confidential Part)

Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing in Myanmar.

Our Core DMF Services – Myanmar

🧪 DMF Preparation – Open & Closed Parts (Myanmar-Compliant)

We prepare complete, structured, and Myanmar FDA–aligned DMF dossiers following the ACTD / CTD format accepted for Myanmar submissions.

Applicant’s Part (Open Part)

Prepared for submission to Myanmar FDA / Local MA Holders / Importers, including:

• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– API Registration
– Finished Product Registration
– Import License & Product Approval
• ACTD/CTD-structured documentation suitable for Myanmar and global exports

Restricted Part (Closed / Confidential Part)

Secure preparation and handling of proprietary technical information, including:

• Detailed manufacturing process and process flow diagrams
• Critical process parameters and in-process controls
• Raw materials, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality system (PQS)
• Stability data as per Zone IVb climatic conditions applicable to Myanmar

✅ Confidential data is disclosed strictly to Myanmar FDA regulators and never to local applicants or distributors.

DMF Types Covered – Myanmar

We support DMF documentation for:

• Type II – Active Pharmaceutical Ingredients (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information

🧪 DMF Review & Gap Assessment – Myanmar

Already have a DMF for Myanmar?

We conduct Myanmar-specific DMF review and risk assessment based on:

• Myanmar FDA technical expectations & inspection practices
• ASEAN GMP compliance gaps
• ACTD/CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely Myanmar FDA deficiency triggers

✔️ You receive a clear, actionable gap assessment report before submission or inspection.

🧪 Myanmar FDA Submission & Regulatory Support

We provide hands-on support for DMF usage and filing in Myanmar, including:

• Myanmar FDA submissions and clarifications
• API registration support
• Finished product registration support
• Import license & product approval dossiers
• Export-linked DMF alignment

Our team ensures:
• Correct ACTD/CTD formatting
• Accurate cross-referencing
• Consistency across DMF, Myanmar FDA dossiers, and manufacturing records

🧪 DMF Lifecycle Management & Maintenance – Myanmar

We manage your DMF throughout its complete regulatory lifecycle, including:

• Initial DMF compilation
• Annual updates and variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• Myanmar FDA–driven amendments and updates

🧪 Post-Submission Deficiency & Query Handling – Myanmar FDA

Complete post-submission regulatory support for Myanmar, including:

• Myanmar FDA deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with MA holder responses
• Coordination between manufacturer, MA holder, and Myanmar FDA authority

🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.

🧪 Why Choose DMF Direct for Myanmar?

🧪 In-depth knowledge of Myanmar FDA regulatory pathways
🧪 Expertise in ASEAN GMP, Myanmar & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong Myanmar FDA deficiency response experience
🧪 Seamless coordination with Myanmar MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength

Industries We Support – Myanmar

• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)

Regulatory Standards Followed – Myanmar

• Myanmar National Drug Law
• Myanmar FDA Guidelines & Regulations
• ASEAN GMP
• ICH Q-Series & M-Series Guidelines
• ACTD / CTD-ready documentation
• WHO GMP & Technical Reports

Your Trusted Partner for DMF Excellence in Myanmar

Whether you are preparing a new DMF, updating an existing dossier, supporting a Myanmar FDA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Myanmar market.

✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven