Drug Master File (DMF) / ASMF Preparation, Review & Regulatory Support Services – Brazil
ANVISA–Compliant DMF / ASMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) / Active Substance Master File (ASMF) preparation, review, submission, and lifecycle management services specifically tailored for the pharmaceutical regulatory framework of Brazil.
Our DMF / ASMF services are designed to meet the expectations of:
ANVISA – Agência Nacional de Vigilância Sanitária, Brazil
Ministry of Health, Federative Republic of Brazil
And comply with:
Brazilian Health Regulatory Law & RDC Regulations
ANVISA GMP & Inspection Requirements
ICH Guidelines
PIC/S GMP
CTD / eCTD dossier formats used for:
• API technical registration (DMF / DIFA) in Brazil
• Finished pharmaceutical product (FPP) registration
• Import license & Marketing Authorization (Registro Sanitário)
• Local MAH & distributor submissions
• Government tenders & hospital supply registrations
• MERCOSUR & LATAM regional export-oriented filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s / MAH / Importer’s Part)
Closed Part (Restricted / Confidential Manufacturer’s Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with ANVISA.
Our Core DMF / ASMF Services – Brazil
🧪 DMF / ASMF Preparation – Open & Closed Parts (ANVISA-Compliant)
We prepare complete, structured, and ANVISA-aligned DMF / ASMF dossiers following CTD/eCTD & Brazil-specific RDC formats accepted for regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to ANVISA / Brazilian MAHs & Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing & quality information
• Cross-reference-ready documentation for:
– New Product Registration (Medicamento Novo / Similar / Genérico)
– Import License & Marketing Authorization
– Local MAH & Distributor Submissions
– Government & Private Hospital Tenders
• CTD-structured documentation suitable for Brazil & MERCOSUR markets
Restricted Part (Closed / Confidential Part)
Secure preparation and controlled handling of proprietary technical information, including:
• Detailed manufacturing process & validation
• Critical process parameters & in-process controls
• Raw materials, intermediates & finished product specifications
• Analytical methods & validation (ICH Q2 + Brazilian Pharmacopoeia)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per Brazil climatic conditions (Zone IVb – Hot & Very Humid)
✅ Confidential data is disclosed only to ANVISA assessors — not to MAHs or commercial partners.
DMF / ASMF Types Covered – Brazil
We support DMF / ASMF documentation for:
• API / Drug Substance (ASMF / DIFA)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information
🧪 DMF / ASMF Review & Gap Assessment – Brazil
Already have a DMF / ASMF for Brazil?
We conduct Brazil-specific DMF / ASMF review and regulatory risk assessment based on:
• ANVISA technical assessment expectations
• PIC/S & ANVISA GMP compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely ANVISA deficiency & technical query triggers
✔️ You receive a clear, actionable gap-assessment report before official submission.
🧪 ANVISA Submission & Brazil Regulatory Support
We provide hands-on support for DMF / ASMF filing and regulatory usage in Brazil, including:
• ANVISA product registration submissions
• API technical file (DIFA) linkage
• Finished product registration dossiers
• Import license & customs documentation
• Government tender & hospital supply regulatory support
• MERCOSUR-aligned regulatory strategy
Our team ensures:
• Correct CTD / eCTD formatting
• Accurate cross-referencing
• Consistency across DMF, application, GMP & stability records
🧪 DMF / ASMF Lifecycle Management & Maintenance – Brazil
We manage your DMF / ASMF throughout its complete regulatory lifecycle, including:
• Initial DMF / ASMF compilation
• Post-approval variations & renewals
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (long-term & accelerated)
• Specification & analytical method revisions
• Authority-driven post-approval changes
🧪 Post-Submission Deficiency & Query Handling – Brazil
Complete post-submission regulatory support, including:
• ANVISA deficiency letters & technical queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Brazilian MAHs & importers
• Coordination between manufacturer, applicant & ANVISA
🎯 Goal: Faster approvals, fewer objections, and ANVISA-ready DMF / ASMF documentation.
🧪 Why Choose DMF Direct for Brazil?
🧪 Strong expertise in ANVISA & Latin American regulatory pathways
🧪 Proven experience with PIC/S GMP & ICH-aligned DMF / ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong post-submission deficiency response expertise
🧪 Seamless coordination with Brazilian MAHs, importers & hospital suppliers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Brazil
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient suppliers
• Packaging material suppliers
• Importers & distributors
• Government & private hospital suppliers
• Tender-based suppliers
• Contract Manufacturing Organizations (CMOs)
Regulatory Standards Followed – Brazil
• Brazilian Health Regulatory Law
• ANVISA RDC Drug Registration Guidelines
• PIC/S GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• Brazilian Pharmacopoeia
• USP / BP / Ph. Eur. (as accepted)
Your Trusted Partner for DMF / ASMF Excellence in Brazil
Whether you are registering a product in Brazil, submitting an API technical file (DIFA), supplying to hospitals or government tenders, or responding to ANVISA regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the Brazilian pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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