Drug Master File (DMF) / ASMF Preparation, Review & Regulatory Support Services – United Kingdom
MHRA-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 United Kingdom’s post-Brexit regulatory framework.
Our DMF/ASMF services are designed to meet the expectations of:
MHRA – Medicines and Healthcare products Regulatory Agency (UK)
UK Department of Health & Social Care (DHSC)
And comply with:
UK Human Medicines Regulations 2012 (as amended)
UK GMP (MHRA aligned with PIC/S & EU GMP principles)
ICH Guidelines
UK CTD / eCTD formats used for:
• API technical registration & ASMF linkage in the UK
• Finished formulation (FPP) marketing authorisation
• Import testing & UK batch certification
• UK-only regulatory procedures (post-Brexit)
• Export-oriented UK regulatory submissions
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 MHRA.
Our Core DMF / ASMF Services – United Kingdom
🧪 DMF / ASMF Preparation – Open & Closed Parts (UK-Compliant)
We prepare complete, structured, and MHRA-aligned ASMF dossiers following UK CTD/eCTD formats accepted for national UK submissions.
Applicant’s Part (Open Part)
Prepared for submission to MHRA / UK 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:
– UK National Marketing Authorisation
– UK Import & Manufacturer’s Authorisation (MIA)
– UK Responsible Person (RP) linkage
• CTD-structured documentation suitable for UK-only 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 + British Pharmacopoeia / Ph. Eur.)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per UK climatic conditions (Zone I – Temperate)
✅ Confidential data is disclosed only to MHRA assessors — not to MAHs or commercial partners.
DMF / ASMF Types Covered – United Kingdom
We support DMF / ASMF documentation for:
• API / Drug Substance (ASMF)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information
🧪 DMF / ASMF Review & Gap Assessment – United Kingdom
Already have a DMF / ASMF for the UK?
We conduct UK-specific DMF / ASMF review and regulatory risk assessment based on:
• MHRA quality assessment expectations
• UK GMP & PIC/S compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely MHRA deficiency & technical query triggers
✔️ You receive a clear, actionable gap assessment report before MHRA submission or inspection.
🧪 MHRA Submission & United Kingdom Regulatory Support
We provide hands-on support for DMF / ASMF filing and regulatory usage in the UK, including:
• MHRA national submissions
• API registration & ASMF technical linkage
• UK import testing & certification documentation
• UK MAH & Responsible Person (RP) regulatory support
• UK-aligned export submissions
Our team ensures:
• Correct UK CTD / eCTD formatting
• Accurate cross-referencing
• Full consistency across DMF/ASMF, marketing authorisation dossiers, and manufacturing records
🧪 DMF / ASMF Lifecycle Management & Maintenance – United Kingdom
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
• MHRA-driven post-approval changes
🧪 Post-Submission Deficiency & Query Handling – United Kingdom
Complete post-submission regulatory support, including:
• MHRA deficiency letters & assessment queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with UK MAHs & Responsible Persons
• Coordination between manufacturer, MAH & MHRA
🎯 Goal: Faster approvals, fewer queries, and MHRA-ready DMF / ASMF documentation.
🧪 Why Choose DMF Direct for the United Kingdom?
🧪 Deep expertise in MHRA post-Brexit regulatory pathways
🧪 Strong experience with UK GMP, PIC/S & ICH-aligned ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven MHRA deficiency & technical query response success
🧪 Seamless coordination with UK MAHs, importers & Responsible Persons (RPs)
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – United Kingdom
• API manufacturers
• Finished formulation (FPP) manufacturers
• Excipient manufacturers
• Packaging material suppliers
• UK importers & MAHs
• Contract Manufacturing Organizations (CMOs)
• Export-focused pharma companies
Regulatory Standards Followed – United Kingdom
• UK Human Medicines Regulations 2012
• MHRA Quality & Registration Guidelines
• UK GMP & PIC/S
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• British Pharmacopoeia & European Pharmacopoeia
• WHO-GMP (where applicable)
Your Trusted Partner for DMF / ASMF Excellence in the United Kingdom
Whether you are preparing a new ASMF for the UK, updating an existing MHRA technical file, supporting a UK-only product registration, appointing a UK MAH & Responsible Person, or responding to MHRA queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the UK market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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✅ UK–EU dual-strategy ASMF version (Brexit-aligned)
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