Drug Master File (DMF) / ASMF Preparation, Review & Regulatory Support Services – Brunei Darussalam
BDMRA–Compliant DMF / ASMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) / Active Substance Master File (ASMF) preparation, review, submission, and lifecycle management services specifically tailored for Brunei Darussalam’s pharmaceutical regulatory framework.
Our DMF / ASMF services are designed to meet the expectations of:
Brunei Darussalam Medicines Regulatory Authority (BDMRA)
Ministry of Health, Brunei Darussalam
And comply with:
Brunei Medicines Order & BDMRA Regulations
ASEAN Harmonized Technical Requirements (ACTR / A-CTD)
WHO-GMP
ICH Guidelines
CTD / A-CTD dossier formats used for:
• API technical approval in Brunei
• Finished pharmaceutical product (FPP) registration
• Import permit & marketing authorization
• Local agent & distributor submissions
• ASEAN regional & export-oriented filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s / Importer’s / MAH Part)
Closed Part (Restricted / Confidential Manufacturer’s Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with BDMRA.
Our Core DMF / ASMF Services – Brunei
🧪 DMF / ASMF Preparation – Open & Closed Parts (Brunei-Compliant)
We prepare complete, structured, and BDMRA-aligned DMF / ASMF dossiers following A-CTD / CTD formats accepted for Brunei regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to BDMRA / Brunei Marketing Authorization Holders (MAHs) & Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing & quality information
• Cross-reference-ready documentation for:
– Brunei National Drug Registration
– Import Permit & Marketing Authorization
– Local Agent & Distributor Submissions
• A-CTD / CTD-structured documentation suitable for Brunei & ASEAN regulatory pathways
Restricted Part (Closed / Confidential Part)
Secure preparation and controlled handling of proprietary technical information, including:
• Detailed manufacturing process & validation
• Critical process parameters & in-process controls
• Raw materials, intermediates & finished product specifications
• Analytical methods & validation (ICH Q2)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per Brunei climatic conditions (Zone IVb – Hot & Very Humid)
✅ Confidential data is disclosed only to BDMRA assessors — not to importers or commercial partners.
DMF / ASMF Types Covered – Brunei
We support DMF / ASMF documentation for:
• API / Drug Substance (ASMF)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information
🧪 DMF / ASMF Review & Gap Assessment – Brunei
Already have a DMF / ASMF for Brunei?
We conduct Brunei-specific DMF / ASMF review and regulatory risk assessment based on:
• BDMRA technical assessment expectations
• WHO-GMP compliance gaps
• A-CTD / CTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely BDMRA deficiency & technical query triggers
✔️ You receive a clear, actionable gap-assessment report before official submission.
🧪 BDMRA Submission & Brunei Regulatory Support
We provide hands-on support for DMF / ASMF filing and regulatory usage in Brunei, including:
• BDMRA product registration submissions
• API technical file linkage
• Finished product registration dossiers
• Import permit & customs documentation
• ASEAN-aligned regulatory strategy
Our team ensures:
• Correct A-CTD / CTD formatting
• Accurate cross-referencing
• Consistency across DMF, application, GMP & stability records
🧪 DMF / ASMF Lifecycle Management & Maintenance – Brunei
We manage your DMF / ASMF throughout its complete regulatory lifecycle, including:
• Initial DMF / ASMF compilation
• Post-approval variations & renewals
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (long-term & accelerated)
• Specification & analytical method revisions
• Authority-driven post-approval changes
🧪 Post-Submission Deficiency & Query Handling – Brunei
Complete post-submission regulatory support, including:
• BDMRA deficiency letters & technical queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Brunei MAHs & importers
• Coordination between manufacturer, applicant & BDMRA
🎯 Goal: Faster approvals, fewer objections, and BDMRA-ready DMF / ASMF documentation.
🧪 Why Choose DMF Direct for Brunei?
🧪 Strong expertise in BDMRA & ASEAN regulatory pathways
🧪 Proven experience with WHO-GMP & ICH-aligned DMF / ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong post-submission deficiency response expertise
🧪 Seamless coordination with Brunei importers & MAHs
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Brunei
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient suppliers
• Packaging material suppliers
• Importers & distributors
• Government & private hospital suppliers
• Contract Manufacturing Organizations (CMOs)
Regulatory Standards Followed – Brunei
• Brunei Medicines Order & BDMRA Regulations
• BDMRA Drug Registration Guidelines
• ASEAN ACTR / A-CTD
• WHO-GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• USP / BP / Ph. Eur. (as accepted)
Your Trusted Partner for DMF / ASMF Excellence in Brunei
Whether you are registering a product in Brunei, submitting an API technical file, supplying to hospitals or government tenders, or responding to BDMRA regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the Brunei pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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