Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Peru
DIGEMID-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 Peru’s regulatory framework.
Our DMF services are designed to meet the expectations of the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) under the Ministry of Health of Peru (MINSA) and align with:
• Peru General Health Law & Pharmaceutical Regulations
• Andean Community (CAN) Technical Standards
• Good Manufacturing Practices (GMP)
• WHO & ICH Guidelines
• CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) approvals
• Import registration 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 regulatory compliance, strict confidentiality, and smooth approval processing in Peru.
Our Core DMF Services – Peru
🧪 DMF Preparation – Open & Closed Parts (Peru–Compliant)
We prepare complete, structured, and DIGEMID-aligned DMF dossiers strictly following the CTD format accepted for Peruvian regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to DIGEMID / Local Marketing Authorization Holders (MAH) / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– Sanitary Registration (Registro Sanitario)
– Import Authorization
– Manufacturing & GMP Certification
• CTD-structured documentation suitable for Peru and Andean Community 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 Peru climatic conditions (Zones II & IVa, as applicable)
✅ Confidential data is disclosed only to DIGEMID regulators and is never shared with applicants or third parties.
DMF Types Covered – Peru
We support 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 – Peru
Already have a DMF for Peru?
We conduct a Peru-specific DMF review and regulatory risk assessment based on:
• DIGEMID expectations and regulatory audit observations
• GMP & Andean technical compliance gaps
• CTD structure and technical content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely DIGEMID deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 DIGEMID Submission & Peru Regulatory Support
We provide hands-on support for DMF usage and registration filing in Peru, including:
• DIGEMID submissions and regulatory clarifications
• API registration support
• Import registration dossiers
• GMP & manufacturing documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Full consistency across DMF, sanitary registration dossier, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Peru
We manage your DMF throughout its complete regulatory lifecycle in Peru, including:
• Initial DMF compilation
• Annual updates, renewals & variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• DIGEMID-driven amendments and compliance updates
🧪 Post-Submission Deficiency & Query Handling – DIGEMID
Complete post-submission regulatory support for Peru, including:
• DIGEMID deficiency letters & technical queries
• Scientific justification & deficiency response drafting
• Revised Open & Closed Part submissions
• Alignment with MAH / local applicant responses
• Coordination between manufacturer, MAH, and DIGEMID
🎯 Goal: Faster approvals, fewer regulatory queries, and authority-ready DMF documentation.
🧪 Why Choose DMF Direct for Peru?
🧪 In-depth knowledge of DIGEMID & Peruvian regulatory pathways
🧪 Expertise in GMP, WHO & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Strong DIGEMID deficiency response experience
🧪 Seamless coordination with Peruvian MAHs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Peru
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient manufacturers
• Packaging material suppliers
• Importers & exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Peru
• Peru General Health Law & Pharmaceutical Regulations
• DIGEMID Guidelines
• Good Manufacturing Practices (GMP)
• WHO & ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• PAHO & WHO Technical Reports
Your Trusted Partner for DMF Excellence in Peru
Whether you are preparing a new DMF, updating an existing dossier, supporting a DIGEMID submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Peruvian and Andean pharmaceutical markets.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven