Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Chennai

CDSCO & Tamil Nadu FDA–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 for pharmaceutical companies, CROs, and manufacturers based in Chennai and across Tamil Nadu.

Our DMF services are fully aligned with the regulatory authorities:

• Central Drugs Standard Control Organization (CDSCO – South Zone), Chennai

• Tamil Nadu State Food & Drug Administration (TN FDA)

And comply with:

• Drugs & Cosmetics Act & Rules, India

• Schedule M (GMP)

• ICH Guidelines

• CTD / eCTD-based dossier formats

Supporting regulatory filings for:

• API registration
• Finished formulation approvals
• Import registration dossiers
• Export-oriented regulatory submissions
• Contract manufacturing & technology transfer filings

We specialize in the preparation and maintenance of both:

1. Open Part (Applicant’s Part)

2. Closed Part (Restricted / Confidential Part)

Ensuring full regulatory compliance, strict confidentiality, and smooth approvals for Chennai-based manufacturers and exporters.

Our Core DMF Services – Chennai

🧪 DMF Preparation – Open & Closed Parts (India & Chennai-Compliant)

We prepare complete, structured, and CDSCO-aligned DMF dossiers in CTD format accepted for India, US, EU, GCC, ASEAN, and global markets.

Applicant’s Part (Open Part) – Chennai

Prepared for submission to CDSCO / Tamil Nadu FDA / Applicants, including:

• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing & quality information
• Cross-reference-ready documentation for:
– Form 44 / New Drug Applications
– Import Registration (Form 10 / Form 41)
– Manufacturing License (Form 25 / Form 28)
– Export Registration Dossiers
• CTD-structured documentation suitable for domestic and international regulatory filings

Restricted Part (Closed / Confidential Part)

Secure preparation and handling of proprietary technical data, including:

• Detailed manufacturing process & flow diagrams
• Critical process parameters & in-process controls
• Raw material, intermediates & finished product specifications
• Analytical methods & validation (ICH Q2)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per Indian climatic conditions (Zone IVb)

✅ Confidential data is accessed only by regulators and never shared with applicants.

DMF Types Covered – Chennai

• Type II – Active Pharmaceutical Ingredients (API)
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information

🧪 DMF Review & Gap Assessment – Chennai

Already have a DMF prepared in Chennai?

We conduct India-specific and export-ready DMF reviews based on:

• CDSCO South Zone & TN FDA inspection expectations
• Schedule M & WHO-GMP compliance gaps
• CTD structure & documentation deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely regulatory deficiency triggers

✔️ You receive a detailed, actionable gap assessment report before submission or inspection.

🧪 CDSCO & Tamil Nadu FDA Submission Support – Chennai

We provide hands-on local regulatory support, including:

• CDSCO South Zone submissions & technical justifications
• Tamil Nadu FDA manufacturing license documentation
• API registration & DMF linkage support
• Import-export regulatory documentation
• Global submission DMF alignment (USA, EU, GCC, Africa, ASEAN)

We ensure:

• Correct CTD / eCTD formatting
• Accurate cross-referencing
• Full consistency across DMF, applications & manufacturing records

🧪 DMF Lifecycle Management & Maintenance – Chennai

We manage your DMF through its complete regulatory lifecycle:

• Initial DMF compilation
• Annual updates & renewals
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (real-time & accelerated)
• API & specification changes
• CDSCO-driven amendments & responses

🧪 Post-Submission Deficiency & Query Handling – Chennai

End-to-end regulatory query & deficiency response management, including:

• CDSCO deficiency letters & TN FDA audit observations
• Scientific justification drafting
• Revised Open & Closed Part submissions
• Alignment with applicant & exporter responses
• Coordination between manufacturer, consultants & regulators

🎯 Goal: Faster approvals, minimal queries, and regulator-ready dossiers.

🧪 Why Choose DMF Direct in Chennai?

🧪 Strong experience with Chennai-based pharma, CRO & biotech companies
🧪 Deep knowledge of CDSCO South Zone & Tamil Nadu FDA processes
🧪 Expertise in Schedule M, WHO-GMP & ICH-aligned DMF
🧪 Secure confidential data handling
🧪 Proven CDSCO deficiency response success
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength

Industries We Support – Chennai

• API manufacturers
• Finished formulation (FDF) manufacturers
• CROs & Bioequivalence study companies
• Biotech & specialty pharma companies
• Excipient & packaging suppliers
• Exporters & importers
• Contract Manufacturing Organizations (CMOs)

Regulatory Standards Followed – Chennai

• Drugs & Cosmetics Act & Rules (India)
• CDSCO & Tamil Nadu FDA Guidelines
• Schedule M (GMP)
• ICH Q & M Series
• CTD / eCTD
• WHO-GMP & Global Regulatory Standards

Your Trusted DMF Partner in Chennai

Whether you are an API manufacturer in Guindy, a formulation unit in Ambattur, a CRO in OMR, or an exporter in Sriperumbudur, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions from Chennai to global markets.

✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven

If you want, I can also create:

✅ SEO landing page for “DMF Services in Chennai”
✅ Tamil Nadu pharma-focused brochure version
✅ Export-specific DMF services page for Chennai manufacturers