Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Spain
AEMPS-Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for Spain’s regulatory framework.
Our DMF services are designed to meet the expectations of the Spanish Agency of Medicines and Medical Devices (AEMPS – Agencia Española de Medicamentos y Productos Sanitarios) and align with:
• Spanish Medicines Law (EU-harmonized)
• EU GMP (EudraLex, Volume 4)
• ICH Guidelines
• EU-CTD / eCTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) approvals
• Import authorization dossiers
• Export-oriented regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s Part)
Closed Part (Restricted / Confidential Part)
Ensuring full EU-level regulatory compliance, strict confidentiality, and smooth approval processing in Spain.
Our Core DMF Services – Spain
🧪 DMF Preparation – Open & Closed Parts (Spain-Compliant)
We prepare complete, structured, and AEMPS-aligned DMF dossiers strictly following the EU-CTD format accepted for Spanish and EU submissions.
Applicant’s Part (Open Part)
Prepared for submission to AEMPS / Marketing Authorization Holders (MAH) / EU Applicants, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– Spanish / EU Marketing Authorization (MA)
– Import Authorization
– Manufacturing & EU-GMP Certification
• EU-CTD structured documentation suitable for Spain and EU markets
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process & process flow diagrams
• Critical process parameters (CPPs) & in-process controls (IPCs)
• Raw materials, intermediates & finished product specifications
• Analytical methods & method validation (ICH Q2(R2))
• Control strategy & pharmaceutical quality system (PQS)
• Stability data as per EU climatic conditions (Zone II)
✅ Confidential data is disclosed only to AEMPS / EMA regulators and is never shared with applicants or third parties.
DMF Types Covered – Spain
We support EU-CTD-based DMF documentation for:
• Type II – Active Pharmaceutical Ingredients (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Spain
Already have a DMF for Spain or the EU?
We conduct a Spain/EU-specific DMF review and regulatory risk assessment based on:
• AEMPS & EMA expectations and inspection observations
• EU-GMP compliance gaps
• CTD structure and technical content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely AEMPS/EMA deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 AEMPS Submission & Spain/EU Regulatory Support
We provide hands-on support for DMF usage and registration filings in Spain and across the EU, including:
• AEMPS submissions and regulatory clarifications
• API registration & CEP-linked DMF support
• Import authorization dossiers
• EU-GMP & manufacturing documentation
• Export-linked DMF alignment
Our team ensures:
• Correct EU-CTD / eCTD formatting
• Accurate cross-referencing
• Full consistency across DMF, MA dossier, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Spain
We manage your DMF throughout its complete regulatory lifecycle in Spain and the EU, including:
• Initial DMF compilation
• Annual updates, variations & renewals
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• AEMPS/EMA-driven variations and compliance updates
🧪 Post-Submission Deficiency & Query Handling – AEMPS / EMA
Complete post-submission regulatory support for Spain and the EU, including:
• AEMPS/EMA deficiency letters & technical queries
• Scientific justification & deficiency response drafting
• Revised Open & Closed Part submissions
• Alignment with MAH responses
• Coordination between manufacturer, MAH, AEMPS & EMA
🎯 Goal: Faster approvals, fewer regulatory queries, and EU-regulator-ready DMF documentation.
🧪 Why Choose DMF Direct for Spain?
🧪 In-depth knowledge of Spanish & EU regulatory pathways
🧪 Expertise in EU-GMP, EMA & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data (GDPR-compliant)
🧪 Strong AEMPS/EMA deficiency response experience
🧪 Seamless coordination with Spanish & EU Marketing Authorization Holders
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Spain
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient manufacturers
• Packaging material suppliers
• Importers & exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Spain
• Spanish Medicines Law (EU-harmonized)
• AEMPS Guidelines
• EU GMP – EudraLex Volume 4
• ICH Q-Series & M-Series Guidelines
• EU-CTD / eCTD-ready documentation
• EMA, EDQM & WHO Technical Reports
Your Trusted Partner for DMF Excellence in Spain
Whether you are preparing a new DMF, updating an existing dossier, supporting an AEMPS/EMA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Spanish and EU pharmaceutical markets.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven