Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Haiti
MSPP / DNPM–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 Haiti’s regulatory framework.
Our DMF services are designed to meet the expectations of the Ministry of Public Health and Population (MSPP), Haiti, through the National Directorate of Pharmacy and Medicine (DNPM) and align with:
• Haitian 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 authorization dossiers
• Public health & donor-supported 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 Haiti.
Our Core DMF Services – Haiti
🧪 DMF Preparation – Open & Closed Parts (Haiti-Compliant)
We prepare complete, structured, and DNPM-aligned DMF dossiers strictly following the CTD format accepted for Haitian regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to the MSPP / DNPM / 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:
– Marketing Authorization
– Import Authorization
– Manufacturing & WHO-GMP Certification
• CTD-structured documentation suitable for Haiti and Caribbean 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 Haiti climatic conditions (Zone IVb – hot & humid)
✅ Confidential data is disclosed only to DNPM regulators and is never shared with applicants or third parties.
DMF Types Covered – Haiti
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 – Haiti
Already have a DMF for Haiti?
We conduct a Haiti-specific DMF review and regulatory risk assessment based on:
• DNPM expectations and regulatory observations
• WHO-GMP compliance gaps
• CTD structure and technical content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely DNPM deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 MSPP / DNPM Submission & Haiti Regulatory Support
We provide hands-on support for DMF usage and registration filing in Haiti, including:
• MSPP / DNPM submissions and regulatory clarifications
• API registration support
• Import authorization dossiers
• GMP & manufacturing documentation
• Donor- and NGO-linked DMF alignment (where applicable)
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Full consistency across DMF, marketing authorization dossier, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Haiti
We manage your DMF throughout its complete regulatory lifecycle in Haiti, 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
• DNPM-driven amendments and compliance updates
🧪 Post-Submission Deficiency & Query Handling – DNPM
Complete post-submission regulatory support for Haiti, including:
• DNPM 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 DNPM
🎯 Goal: Faster approvals, fewer regulatory queries, and authority-ready DMF documentation.
🧪 Why Choose DMF Direct for Haiti?
🧪 In-depth knowledge of Haiti MSPP & DNPM regulatory pathways
🧪 Expertise in WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Strong DNPM deficiency response experience
🧪 Seamless coordination with Haitian MAHs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Haiti
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient manufacturers
• Packaging material suppliers
• Importers & exporters
• Contract manufacturing organizations (CMOs)
• NGO & humanitarian supply programs
Regulatory Standards Followed – Haiti
• Haitian Public Health Law & Pharmaceutical Regulations
• MSPP / DNPM Guidelines
• WHO Good Manufacturing Practices (WHO-GMP)
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO Technical Reports
Your Trusted Partner for DMF Excellence in Haiti
Whether you are preparing a new DMF, updating an existing dossier, supporting an MSPP / DNPM submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Haitian pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven