Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Venezuela
INHRR-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 Venezuela’s regulatory framework.
Our DMF services are designed to meet the expectations of the National Institute of Hygiene “Rafael Rangel” (INHRR) under the Ministry of Popular Power for Health (MPPS), Venezuela, and align with:
• Venezuelan Organic Health Law & Pharmaceutical Regulations
• Good Manufacturing Practices (GMP)
• WHO & 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 Venezuela.
Our Core DMF Services – Venezuela
🧪 DMF Preparation – Open & Closed Parts (Venezuela–Compliant)
We prepare complete, structured, and INHRR-aligned DMF dossiers strictly following the CTD format accepted for Venezuelan regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to MPPS / INHRR / 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:
– Sanitary Registration (Registro Sanitario)
– Import Authorization
– Manufacturing & GMP Certification
• CTD-structured documentation suitable for Venezuela and Latin American 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 Venezuela climatic conditions (Zone IVa–IVb, as applicable)
✅ Confidential data is disclosed only to INHRR regulators and is never shared with applicants or third parties.
DMF Types Covered – Venezuela
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 – Venezuela
Already have a DMF for Venezuela?
We conduct a Venezuela-specific DMF review and regulatory risk assessment based on:
• INHRR expectations and regulatory audit observations
• GMP & WHO compliance gaps
• CTD structure and technical content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely INHRR deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 INHRR Submission & Venezuela Regulatory Support
We provide hands-on support for DMF usage and registration filing in Venezuela, including:
• INHRR 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, sanitary registration dossier, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Venezuela
We manage your DMF throughout its complete regulatory lifecycle in Venezuela, 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
• INHRR-driven amendments and compliance updates
🧪 Post-Submission Deficiency & Query Handling – INHRR
Complete post-submission regulatory support for Venezuela, including:
• INHRR 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 INHRR
🎯 Goal: Faster approvals, fewer regulatory queries, and authority-ready DMF documentation.
🧪 Why Choose DMF Direct for Venezuela?
🧪 In-depth knowledge of INHRR & Venezuelan regulatory pathways
🧪 Expertise in GMP, WHO & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Strong INHRR deficiency response experience
🧪 Seamless coordination with Venezuelan MAHs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Venezuela
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient manufacturers
• Packaging material suppliers
• Importers & exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Venezuela
• Venezuelan Organic Health Law & Pharmaceutical Regulations
• INHRR & MPPS Guidelines
• Good Manufacturing Practices (GMP)
• WHO & ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO & PAHO Technical Reports
Your Trusted Partner for DMF Excellence in Venezuela
Whether you are preparing a new DMF, updating an existing dossier, supporting an INHRR submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Venezuelan and Latin American pharmaceutical markets.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven