Drug Master File (DMF) / ASMF Preparation, Review & Regulatory Support Services – Israel
Israeli Ministry of Health (MOH)–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 Israel’s regulatory framework.
Our DMF/ASMF services are designed to meet the expectations of:
Israeli Ministry of Health (MOH) – Pharmaceutical Division (AMAR)
Institute for the Standardization and Control of Pharmaceuticals (where applicable)
And comply with:
Israeli Pharmacy Ordinance & Regulations
Israeli GMP (aligned with EU GMP / PIC/S)
ICH Guidelines
CTD / eCTD dossier formats used for:
• API technical registration & ASMF linkage in Israel
• Finished formulation (FPP) product registration
• Import marketing authorization dossiers
• Local MAH & distributor submissions
• Export-oriented Israel regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s / MAH Part)
Closed Part (Restricted / Confidential Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with Israel MOH.
Our Core DMF / ASMF Services – Israel
🧪 DMF / ASMF Preparation – Open & Closed Parts (Israel-Compliant)
We prepare complete, structured, and MOH-aligned ASMF dossiers following CTD/eCTD formats accepted for Israeli submissions.
Applicant’s Part (Open Part)
Prepared for submission to Israel MOH / Local Marketing Authorization Holders (MAHs), including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– Israeli National Drug Registration
– Import & Distribution Licensing
– Local MAH & Agent Submissions
• CTD-structured documentation suitable for Israel and global 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 + USP / Ph. Eur./ BP as accepted by MOH)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per Israel climatic conditions (Zone II – Hot / Dry to Temperate)
✅ Confidential data is disclosed only to Israel MOH assessors — not to MAHs or commercial partners.
DMF / ASMF Types Covered – Israel
We support DMF / ASMF documentation for:
• API / Drug Substance (ASMF)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information
🧪 DMF / ASMF Review & Gap Assessment – Israel
Already have a DMF / ASMF for Israel?
We conduct Israel-specific DMF / ASMF review and regulatory risk assessment based on:
• Israel MOH (AMAR) quality assessment expectations
• Israeli GMP & PIC/S compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely Israel MOH deficiency & technical query triggers
✔️ You receive a clear, actionable gap assessment report before Israel MOH submission or inspection.
🧪 Israel MOH Submission & Israel Regulatory Support
We provide hands-on support for DMF / ASMF filing and regulatory usage in Israel, including:
• Israel MOH electronic & paper submissions
• API registration & ASMF technical linkage
• Product registration dossiers (FPP)
• Import permit & MAH documentation
• Export-linked Israel regulatory alignment
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 – Israel
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
• Israel MOH-driven post-approval changes
🧪 Post-Submission Deficiency & Query Handling – Israel
Complete post-submission regulatory support, including:
• Israel MOH deficiency letters & technical queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Israeli MAHs & local agents
• Coordination between manufacturer, MAH & Israel MOH
🎯 Goal: Faster approvals, fewer queries, and Israel MOH-ready DMF / ASMF documentation.
🧪 Why Choose DMF Direct for Israel?
🧪 Deep expertise in Israel MOH (AMAR) regulatory pathways
🧪 Strong experience with Israeli GMP, PIC/S & ICH-aligned ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven Israel MOH deficiency & technical query response success
🧪 Seamless coordination with Israeli MAHs, importers & local agents
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Israel
• API manufacturers
• Finished formulation (FPP) manufacturers
• Excipient manufacturers
• Packaging material suppliers
• Israeli importers & MAHs
• Contract Manufacturing Organizations (CMOs)
• Export-focused pharma companies
Regulatory Standards Followed – Israel
• Israeli Pharmacy Ordinance & MOH Regulations
• Israel MOH (AMAR) Guidelines
• Israeli GMP (PIC/S aligned)
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• USP / Ph. Eur. / BP (as accepted by MOH)
• WHO-GMP (where applicable)
Your Trusted Partner for DMF / ASMF Excellence in Israel
Whether you are preparing a new ASMF for Israel, updating an existing MOH technical file, supporting a national drug registration, appointing an Israeli MAH & importer, or responding to Israel MOH queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the Israeli pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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