Drug Master File (DMF) / ASMF Preparation, Review & Regulatory Support Services – New Zealand
Medsafe–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 New Zealand’s regulatory framework.
Our DMF/ASMF services are designed to meet the expectations of:
Medsafe – New Zealand Medicines and Medical Devices Safety Authority
Ministry of Health, New Zealand
And comply with:
Medicines Act 1981 & Medicines Regulations 1984
Medsafe Registration & Quality Guidelines
New Zealand GMP (PIC/S aligned)
ICH Guidelines
CTD / eCTD dossier formats used for:
• API technical registration & ASMF linkage in New Zealand
• Finished formulation (FPP) product registration
• Import & distribution authorization dossiers
• Local Sponsor & Distributor submissions
• Export-oriented New Zealand regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s / Sponsor’s Part)
Closed Part (Restricted / Confidential Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with Medsafe.
Our Core DMF / ASMF Services – New Zealand
🧪 DMF / ASMF Preparation – Open & Closed Parts (New Zealand–Compliant)
We prepare complete, structured, and Medsafe-aligned ASMF dossiers following CTD/eCTD formats accepted for New Zealand submissions.
Applicant’s Part (Open Part)
Prepared for submission to Medsafe / New Zealand Sponsors & Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– New Zealand National Medicine Registration
– Import Licensing & Distribution Approval
– Local Sponsor & Agent Submissions
• CTD-structured documentation suitable for New Zealand and international regulatory filings
Restricted Part (Closed / Confidential Part)
Secure preparation and controlled handling of proprietary technical information, including:
• Detailed manufacturing process & process validation
• Critical process parameters & in-process controls
• Raw materials, intermediates & finished product specifications
• Analytical methods & validation (ICH Q2 + BP / Ph. Eur. / USP as accepted by Medsafe)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per New Zealand climatic conditions (Zone I – Temperate)
✅ Confidential data is disclosed only to Medsafe assessors — not to sponsors or commercial partners.
DMF / ASMF Types Covered – New Zealand
We support DMF / ASMF documentation for:
• API / Drug Substance (ASMF)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information
🧪 DMF / ASMF Review & Gap Assessment – New Zealand
Already have a DMF / ASMF for New Zealand?
We conduct New Zealand–specific DMF / ASMF review and regulatory risk assessment based on:
• Medsafe quality assessment expectations
• New Zealand GMP & PIC/S compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely Medsafe deficiency & technical query triggers
✔️ You receive a clear, actionable gap assessment report before Medsafe submission or inspection.
🧪 Medsafe Submission & New Zealand Regulatory Support
We provide hands-on support for DMF / ASMF filing and regulatory usage in New Zealand, including:
• Medsafe electronic submissions
• API technical file linkage
• Finished product registration dossiers
• Import & distribution licensing documentation
• Local Sponsor & authorized importer coordination
Our team ensures:
• Correct CTD / eCTD formatting
• Accurate cross-referencing
• Full consistency across DMF/ASMF, marketing authorization dossiers, and manufacturing records
🧪 DMF / ASMF Lifecycle Management & Maintenance – New Zealand
We manage your DMF / ASMF through its complete regulatory lifecycle, including:
• Initial ASMF compilation
• Annual updates & variations
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• Medsafe-driven post-approval changes
🧪 Post-Submission Deficiency & Query Handling – New Zealand
Complete post-submission regulatory support, including:
• Medsafe deficiency letters & technical queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with New Zealand Sponsors & importers
• Coordination between manufacturer, sponsor & Medsafe
🎯 Goal: Faster approvals, fewer queries, and Medsafe-ready DMF / ASMF documentation.
🧪 Why Choose DMF Direct for New Zealand?
🧪 Deep expertise in Medsafe regulatory pathways
🧪 Strong experience with NZ GMP, PIC/S & ICH-aligned ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven Medsafe deficiency & technical query response success
🧪 Seamless coordination with New Zealand Sponsors, importers & agents
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – New Zealand
• API manufacturers
• Finished formulation (FPP) manufacturers
• Excipient manufacturers
• Packaging material suppliers
• New Zealand importers & sponsors
• Contract Manufacturing Organizations (CMOs)
• Export-focused pharma companies
Regulatory Standards Followed – New Zealand
• Medicines Act & Regulations, New Zealand
• Medsafe Registration & Quality Guidelines
• New Zealand GMP (PIC/S aligned)
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• BP / Ph. Eur. / USP (as accepted by Medsafe)
• WHO-GMP (where applicable)
Your Trusted Partner for DMF / ASMF Excellence in New Zealand
Whether you are preparing a new ASMF for New Zealand, updating an existing Medsafe technical file, supporting a national product registration, appointing a New Zealand Sponsor & importer, or responding to Medsafe queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the New Zealand pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
If you want, I can also prepare:
✅ New Zealand–Australia (TGA) dual-strategy ASMF version
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✅ Export-focused New Zealand DMF services page for Indian API & FDF companies