Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Bangladesh
DGDA-Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides complete Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for Bangladesh’s regulatory framework.
Our DMF services are designed to meet the expectations of the Directorate General of Drug Administration (DGDA), Bangladesh and comply with:
Bangladesh Drugs Act & Rules
GMP Guidelines of DGDA
ICH Guidelines
CTD-based submissions used for:
• API registration
• Finished formulation approvals
• Import registration dossiers
• Export-oriented regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s Part)
Closed Part (Restricted / Confidential Part)
Ensuring regulatory compliance, strict confidentiality, and smooth approval processing in Bangladesh.
Our Core DMF Services – Bangladesh
🧪 DMF Preparation – Open & Closed Parts (Bangladesh-Compliant)
We prepare complete, structured, and DGDA-aligned DMF dossiers following the CTD format accepted for Bangladesh submissions.
Applicant’s Part (Open Part)
Prepared for submission to DGDA / Local Applicants / 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 Permit & Market Authorization
• CTD-structured documentation suitable for Bangladesh 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 quality assurance systems
• Stability data as per Bangladesh climatic conditions (Zone IVb)
✅ Confidential data is disclosed only to DGDA regulators and never to local applicants or importers.
DMF Types Covered – Bangladesh
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 – Bangladesh
Already have a DMF for Bangladesh?
We conduct Bangladesh-specific DMF review and risk assessment based on:
• DGDA expectations and inspection trends
• GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely DGDA deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 DGDA Submission & Bangladesh Regulatory Support
We provide hands-on support for DMF usage and filing in Bangladesh, including:
• DGDA submissions and clarifications
• API registration support
• Import registration dossiers
• Finished product registration support
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, registration dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Bangladesh
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and renewals
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• DGDA-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – DGDA
Complete post-submission regulatory support for Bangladesh, including:
• DGDA deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with local applicant responses
• Coordination between manufacturer, importer, and DGDA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Bangladesh?
🧪 In-depth knowledge of DGDA regulatory pathways
🧪 Expertise in Bangladesh GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong DGDA deficiency response experience
🧪 Seamless coordination with Bangladesh importers and applicants
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Bangladesh
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Bangladesh
• Bangladesh Drugs Act & Rules
• DGDA Guidelines
• Bangladesh GMP Regulations
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Bangladesh
Whether you are preparing a new DMF, updating an existing dossier, supporting a DGDA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Bangladesh market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven