Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Bhutan
DRA Bhutan–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 Bhutan’s regulatory framework.
Our DMF services are designed to meet the requirements of the Drug Regulatory Authority of Bhutan (DRA) and comply with:
Medicines Act of the Kingdom of Bhutan
Bhutan Medicines Rules & Regulations
GMP Guidelines adopted by DRA
ICH Guidelines
CTD-based submissions used for:
• API registration
• Finished formulation approvals
• Import authorization 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 full regulatory compliance, strict confidentiality, and smooth approval processing in Bhutan.
Our Core DMF Services – Bhutan
🧪 DMF Preparation – Open & Closed Parts (Bhutan-Compliant)
We prepare complete, structured, and DRA-aligned DMF dossiers following the CTD format accepted for Bhutan submissions.
Applicant’s Part (Open Part)
Prepared for submission to DRA Bhutan / 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 Authorization & Market Approval
• CTD-structured documentation suitable for Bhutan 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 Bhutan climatic conditions (Zone IVb)
✅ Confidential data is disclosed strictly to DRA regulators and never to local applicants or importers.
DMF Types Covered – Bhutan
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 – Bhutan
Already have a DMF for Bhutan?
We conduct Bhutan-specific DMF review and risk assessment based on:
• DRA expectations and inspection practices
• GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely DRA deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 DRA Submission & Bhutan Regulatory Support
We provide hands-on support for DMF usage and filing in Bhutan, including:
• DRA Bhutan submissions and clarifications
• API registration support
• Import authorization 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 – Bhutan
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
• DRA-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – DRA Bhutan
Complete post-submission regulatory support for Bhutan, including:
• DRA 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 DRA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Bhutan?
🧪 In-depth knowledge of DRA Bhutan regulatory pathways
🧪 Expertise in Bhutan GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong DRA deficiency response experience
🧪 Seamless coordination with Bhutan importers and applicants
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Bhutan
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Bhutan
• Medicines Act of Bhutan
• DRA Bhutan Rules & Guidelines
• Bhutan GMP Regulations
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Bhutan
Whether you are preparing a new DMF, updating an existing dossier, supporting a DRA Bhutan submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Bhutan market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven