Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Moldova
AMDM-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 Moldova’s regulatory framework.
Our DMF services are designed to meet the expectations of the Medicines and Medical Devices Agency of the Republic of Moldova (AMDM) and align with:
• Law on Medicinal Products of the Republic of Moldova
• Good Manufacturing Practices (GMP) – EU-aligned
• ICH Guidelines
• CTD / EU-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 Moldova.
Our Core DMF Services – Moldova
🧪 DMF Preparation – Open & Closed Parts (Moldova-Compliant)
We prepare complete, structured, and AMDM-aligned DMF dossiers strictly following the CTD / EU-CTD format accepted for Moldovan submissions.
Applicant’s Part (Open Part)
Prepared for submission to AMDM / 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 (MA)
– Import Authorization
– Manufacturing & GMP Certification
• CTD-structured documentation suitable for Moldova and CIS/EU-linked 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 Moldova climatic conditions (Zone II)
✅ Confidential data is disclosed only to AMDM regulators and is never shared with applicants or third parties.
DMF Types Covered – Moldova
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 – Moldova
Already have a DMF for Moldova?
We conduct a Moldova-specific DMF review and regulatory risk assessment based on:
• AMDM expectations and inspection observations
• EU-aligned GMP compliance gaps
• CTD structure and technical content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely AMDM deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 AMDM Submission & Moldova Regulatory Support
We provide hands-on support for DMF usage and registration filings in Moldova, including:
• AMDM submissions and regulatory clarifications
• API registration support
• Import registration dossiers
• GMP & manufacturing documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD / EU-CTD formatting
• Accurate cross-referencing
• Full consistency across DMF, MA dossier, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Moldova
We manage your DMF throughout its complete regulatory lifecycle in Moldova, including:
• Initial DMF compilation
• Annual updates, variations & renewals
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• AMDM-driven variations and compliance updates
🧪 Post-Submission Deficiency & Query Handling – AMDM
Complete post-submission regulatory support for Moldova, including:
• AMDM 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 AMDM
🎯 Goal: Faster approvals, fewer regulatory queries, and authority-ready DMF documentation.
🧪 Why Choose DMF Direct for Moldova?
🧪 In-depth knowledge of AMDM & Moldova regulatory pathways
🧪 Expertise in EU-aligned GMP & ICH-based DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Strong AMDM deficiency response experience
🧪 Seamless coordination with Moldovan MAHs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Moldova
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient manufacturers
• Packaging material suppliers
• Importers & exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Moldova
• Law on Medicinal Products – Republic of Moldova
• AMDM Guidelines
• EU-Aligned GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• EMA, WHO & EU Technical Reports
Your Trusted Partner for DMF Excellence in Moldova
Whether you are preparing a new DMF, updating an existing dossier, supporting an AMDM submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Moldovan pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven