Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Suriname
BOG-Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for Suriname’s regulatory framework.
Our DMF services are designed to meet the expectations of the Bureau for Public Health (BOG), Ministry of Health, Suriname, and align with:
• Suriname Public Health Law & Pharmaceutical Regulations
• WHO Good Manufacturing Practices (WHO-GMP)
• ICH Guidelines
• CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) 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 full regulatory compliance, strict confidentiality, and smooth approval processing in Suriname.
Our Core DMF Services – Suriname
🧪 DMF Preparation – Open & Closed Parts (Suriname–Compliant)
We prepare complete, structured, and BOG-aligned DMF dossiers strictly following the CTD format accepted for Surinamese regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to the Ministry of Health / BOG / Local Marketing Authorization Holders (MAH) / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– Product Registration
– Import Permit
– Manufacturing & WHO-GMP Certification
• CTD-structured documentation suitable for Suriname and CARICOM markets
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process & process flow diagrams
• Critical process parameters (CPPs) & in-process controls (IPCs)
• Raw materials, intermediates & finished product specifications
• Analytical methods & method validation (ICH Q2(R2))
• Control strategy & pharmaceutical quality system (PQS)
• Stability data as per Suriname climatic conditions (Zone IVb – hot & humid)
✅ Confidential data is disclosed only to BOG regulators and is never shared with applicants or third parties.
DMF Types Covered – Suriname
We support CTD-based 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 – Suriname
Already have a DMF for Suriname?
We conduct a Suriname-specific DMF review and regulatory risk assessment based on:
• BOG expectations and regulatory observations
• WHO-GMP compliance gaps
• CTD structure and technical content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely BOG deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 BOG Submission & Suriname Regulatory Support
We provide hands-on support for DMF usage and registration filing in Suriname, including:
• BOG submissions and regulatory clarifications
• API registration support
• Import registration dossiers
• GMP & manufacturing documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Full consistency across DMF, product registration dossier, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Suriname
We manage your DMF throughout its complete regulatory lifecycle in Suriname, including:
• Initial DMF compilation
• Annual updates, renewals & variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• BOG-driven amendments and compliance updates
🧪 Post-Submission Deficiency & Query Handling – BOG
Complete post-submission regulatory support for Suriname, including:
• BOG deficiency letters & technical queries
• Scientific justification & deficiency response drafting
• Revised Open & Closed Part submissions
• Alignment with MAH / local applicant responses
• Coordination between manufacturer, MAH, and BOG
🎯 Goal: Faster approvals, fewer regulatory queries, and authority-ready DMF documentation.
🧪 Why Choose DMF Direct for Suriname?
🧪 In-depth knowledge of BOG & Suriname regulatory pathways
🧪 Expertise in WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Strong BOG deficiency response experience
🧪 Seamless coordination with Surinamese MAHs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Suriname
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient manufacturers
• Packaging material suppliers
• Importers & exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Suriname
• Suriname Public Health Law & Pharmaceutical Regulations
• Bureau for Public Health (BOG) Guidelines
• WHO Good Manufacturing Practices (WHO-GMP)
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO & PAHO Technical Reports
Your Trusted Partner for DMF Excellence in Suriname
Whether you are preparing a new DMF, updating an existing dossier, supporting a BOG submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Surinamese and CARICOM pharmaceutical markets.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven