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