Drug Master File (DMF) / ASMF Preparation, Review & Regulatory Support Services – Colombia
INVIMA–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 the Republic of Colombia.
Our DMF / ASMF services are designed to meet the expectations of:
INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Ministry of Health & Social Protection, Colombia
And comply with:
Colombian Decree 677/1995 & Related Medicines Regulations
INVIMA Drug Registration Guidelines
WHO-GMP & PIC/S-aligned GMP
ICH Guidelines
CTD / eCTD dossier formats used for:
• API technical approval in Colombia
• Finished pharmaceutical product (FPP) registration
• Sanitary Registration (Registro Sanitario)
• Import license & Marketing Authorization
• Local MAH & distributor submissions
• Government tenders & hospital supply registrations
• Andean Community (CAN) & LATAM 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 INVIMA.
Our Core DMF / ASMF Services – Colombia
🧪 DMF / ASMF Preparation – Open & Closed Parts (INVIMA-Compliant)
We prepare complete, structured, and INVIMA-aligned DMF / ASMF dossiers following CTD/eCTD formats accepted for Colombian regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to INVIMA / Colombian 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
– Sanitary Registration (Registro Sanitario)
– Import License & Marketing Authorization
– Local MAH & Distributor Submissions
– Government & Private Hospital Tenders
• CTD-structured documentation suitable for Colombia & Andean 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 + Colombian Pharmacopoeia)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per Colombia climatic conditions (Zone IVa – Hot & Humid)
✅ Confidential data is disclosed only to INVIMA assessors — not to MAHs or commercial partners.
DMF / ASMF Types Covered – Colombia
We support DMF / ASMF documentation for:
• API / Drug Substance (ASMF)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information
🧪 DMF / ASMF Review & Gap Assessment – Colombia
Already have a DMF / ASMF for Colombia?
We conduct Colombia-specific DMF / ASMF review and regulatory risk assessment based on:
• INVIMA technical assessment expectations
• WHO-GMP & PIC/S compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely INVIMA deficiency & technical query triggers
✔️ You receive a clear, actionable gap-assessment report before official submission.
🧪 INVIMA Submission & Colombia Regulatory Support
We provide hands-on support for DMF / ASMF filing and regulatory usage in Colombia, including:
• INVIMA product registration submissions
• API technical file linkage
• Finished product registration dossiers
• Import license & customs documentation
• Government tender & hospital supply regulatory support
• Andean region–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 – Colombia
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 – Colombia
Complete post-submission regulatory support, including:
• INVIMA deficiency letters & technical queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Colombian MAHs & importers
• Coordination between manufacturer, applicant & INVIMA
🎯 Goal: Faster approvals, fewer objections, and INVIMA-ready DMF / ASMF documentation.
🧪 Why Choose DMF Direct for Colombia?
🧪 Strong expertise in INVIMA & Latin American regulatory pathways
🧪 Proven experience with WHO-GMP, PIC/S & ICH-aligned DMF / ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong post-submission deficiency response expertise
🧪 Seamless coordination with Colombian MAHs, importers & hospital suppliers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Colombia
• 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 – Colombia
• Colombian Medicines Law & Decree 677/1995
• INVIMA Drug Registration Guidelines
• WHO-GMP & PIC/S
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• Colombian Pharmacopoeia
• USP / BP / Ph. Eur. (as accepted)
Your Trusted Partner for DMF / ASMF Excellence in Colombia
Whether you are registering a product in Colombia, submitting an API technical file, supplying to hospitals or government tenders, or responding to INVIMA regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the Colombian pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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