Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Indonesia
BPOM-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 Indonesia’s regulatory framework.
Our DMF services are designed to meet the expectations of the Badan Pengawas Obat dan Makanan (BPOM), Indonesia and comply with:
Indonesian Drug & Food Law
BPOM Registration & GMP Regulations
ASEAN GMP & ASEAN CTD (ACTD)
ICH Guidelines
CTD / ACTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & distribution authorization
• 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 Indonesia.
Our Core DMF Services – Indonesia
🧪 DMF Preparation – Open & Closed Parts (Indonesia-Compliant)
We prepare complete, structured, and BPOM-aligned DMF dossiers following the ACTD / CTD format accepted for Indonesia submissions.
Applicant’s Part (Open Part)
Prepared for submission to BPOM / 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 (BPOM NIE)
– Import License & Distribution Authorization
• ACTD/CTD-structured documentation suitable for Indonesia 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 Indonesia
✅ Confidential data is disclosed strictly to BPOM regulators and never to local applicants or distributors.
DMF Types Covered – Indonesia
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 – Indonesia
Already have a DMF for Indonesia?
We conduct Indonesia-specific DMF review and risk assessment based on:
• BPOM technical expectations & inspection trends
• ASEAN GMP & BPOM GMP compliance gaps
• ACTD/CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely BPOM deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 BPOM Submission & Indonesia Regulatory Support
We provide hands-on support for DMF usage and filing in Indonesia, including:
• BPOM submissions and clarifications
• API registration support
• Finished product registration (NIE)
• Import license & distribution authorization dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct ACTD/CTD formatting
• Accurate cross-referencing
• Consistency across DMF, BPOM dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Indonesia
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
• BPOM-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – BPOM
Complete post-submission regulatory support for Indonesia, including:
• BPOM 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 BPOM authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Indonesia?
🧪 In-depth knowledge of BPOM regulatory pathways
🧪 Expertise in ASEAN GMP, BPOM & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong BPOM deficiency response experience
🧪 Seamless coordination with Indonesian MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Indonesia
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Indonesia
• Indonesian Drug & Food Law
• BPOM Regulations & Guidelines
• ASEAN GMP
• ICH Q-Series & M-Series Guidelines
• ACTD / CTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Indonesia
Whether you are preparing a new DMF, updating an existing dossier, supporting a BPOM submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Indonesian market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven