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