Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Tajikistan

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SSSPA Tajikistan–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 Tajikistan’s regulatory framework.

Our DMF services are designed to meet the expectations of the State Service for Supervision of Pharmaceutical Activities (SSSPA), Ministry of Health & Social Protection of Population, Republic of Tajikistan, and align with:

• Law on Medicines and Pharmaceutical Activities – Republic of Tajikistan
• SSSPA Guidelines for Registration of Medicinal Products
• WHO GMP Standards
• ICH Guidelines
• CTD-based documentation formats
• CIS / EAEU-aligned regulatory practices (where referenced)

Used for:

• API registration
• Finished formulation product registration
• Import authorization dossiers
• Export-oriented regulatory filings

We specialize in the preparation and maintenance of both:

1. Open Part (Applicant’s Part)

2. Closed Part (Restricted / Confidential Part)

Ensuring full regulatory compliance, confidentiality, and smooth approval processing in Tajikistan.

Our Core DMF Services – Tajikistan

🧪 DMF Preparation – Open & Closed Parts (Tajikistan-Compliant)

We prepare complete, structured, and SSSPA-aligned DMF dossiers following CTD format accepted for Tajikistan submissions.

Applicant’s Part (Open Part)

Prepared for submission to SSSPA Tajikistan / Local Marketing Authorization Holders / 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 authorization
– Marketing authorization
• CTD-structured documentation suitable for Tajikistan and regional CIS markets

Restricted Part (Closed / Confidential Part)

Secure preparation and handling of proprietary technical information, including:

• Detailed manufacturing process and validated process flow diagrams
• Critical process parameters and in-process controls
• Raw material, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality systems
• Stability data as per WHO Climatic Zone II / IVa (as applicable to Tajikistan)

✅ Confidential information is disclosed only to SSSPA regulators and never to applicants.

DMF Types Covered – Tajikistan

We support DMF documentation for:

• Type II – Active Pharmaceutical Ingredient (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information

🧪 DMF Review & Gap Assessment – Tajikistan

Already have a DMF for Tajikistan?
We conduct Tajikistan-specific DMF review and risk assessment based on:

• SSSPA regulatory expectations and expert assessment remarks
• WHO GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely SSSPA technical deficiency triggers

✔️ You receive a clear, actionable gap assessment report prior to submission.

🧪 SSSPA Submission & Tajikistan Regulatory Support

We provide hands-on regulatory support including:

• SSSPA submissions and technical clarifications
• API registration support
• Import authorization dossier preparation
• Finished product registration documentation
• Export-linked DMF alignment

Our team ensures:

• Correct CTD formatting
• Accurate technical cross-referencing
• Full consistency across DMF, product dossiers, and manufacturing documents

🧪 DMF Lifecycle Management & Maintenance – Tajikistan

We manage your DMF throughout its complete regulatory lifecycle, including:

• Initial DMF compilation
• Variations, updates, and renewals
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (accelerated & long-term)
• Specification and analytical method revisions
• SSSPA-driven amendments and updates

🧪 Post-Submission Deficiency & Query Handling – SSSPA Tajikistan

Complete post-submission regulatory support, including:

• SSSPA deficiency letters and expert queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with applicant responses
• Coordination between manufacturer, importer, and SSSPA authority

🎯 Goal: Faster approvals, fewer queries, and regulator-ready DMF documentation.

🧪 Why Choose DMF Direct for Tajikistan?

🧪 In-depth knowledge of SSSPA & CIS regulatory pathways
🧪 Strong expertise in WHO GMP and ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Proven success in regulatory deficiency responses
🧪 Seamless coordination with Tajik importers & MA holders
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength

Industries We Support – Tajikistan

• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and distributors
• Contract manufacturing organizations (CMOs)

Regulatory Standards Followed – Tajikistan

• Law on Medicines – Republic of Tajikistan
• SSSPA Tajikistan Guidelines
• WHO GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• CIS technical practices (where applicable)

Your Trusted Partner for DMF Excellence in Tajikistan

Whether you are preparing a new DMF, updating an existing dossier, supporting an SSSPA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Tajikistan pharmaceutical market.

✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven