Drug Master File (DMF) Preparation, Review & Regulatory Support Services – India
CDSCO-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 India’s regulatory framework.
Our DMF services are designed to meet the expectations of the Central Drugs Standard Control Organization (CDSCO) and comply with:
Drugs & Cosmetics Act & Rules, India
Schedule M (GMP)
ICH Guidelines
CTD-based submissions used for:
• API registration
• Finished formulation 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 complete regulatory compliance, strict confidentiality, and smooth approval processing in India.
Our Core DMF Services – India
🧪 DMF Preparation – Open & Closed Parts (India-Compliant)
We prepare complete, structured, and CDSCO-aligned DMF dossiers following the CTD format accepted for Indian submissions.
Applicant’s Part (Open Part)
Prepared for submission to CDSCO / State FDA / Applicants, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– Form 44
– Import Registration (Form 41 / Form 10)
– Manufacturing License (Form 25 / Form 28)
• CTD-structured documentation suitable for India and global exports
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process and process flow diagrams
• Critical process parameters and in-process controls
• Raw materials, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and quality assurance systems
• Stability data as per Indian climatic conditions (Zone IVb)
✅ Confidential data is protected and disclosed only to CDSCO regulators, not applicants.
DMF Types Covered – India
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredient (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – India
Already have a DMF for India?
We conduct India-specific DMF review and risk assessment based on:
• CDSCO expectations and Indian audit observations
• Schedule M & GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely CDSCO deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 CDSCO Submission & India Regulatory Support
We provide hands-on support for DMF usage and filing in India, including:
• CDSCO submissions and clarifications
• API registration support
• Import registration dossiers
• Manufacturing license documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, application, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – India
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and renewals
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• CDSCO-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – CDSCO
Complete post-submission regulatory support for India, including:
• CDSCO deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with applicant responses
• Coordination between manufacturer, applicant, and CDSCO authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for India?
🧪 In-depth knowledge of CDSCO & Indian regulatory pathways
🧪 Expertise in Schedule M and ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong CDSCO deficiency response experience
🧪 Seamless coordination with Indian applicants and license holders
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – India
• API manufacturers
• Formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – India
• Drugs & Cosmetics Act and Rules, India
• CDSCO Guidelines
• Schedule M (GMP)
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in India
Whether you are preparing a new DMF, updating an existing dossier, supporting a CDSCO submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Indian market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven