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

CDSCO West Zone & Gujarat 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 API manufacturers, formulation units, chemical-pharma companies, exporters, and contract manufacturers based in Vapi and the South Gujarat industrial belt.

Our DMF services are fully aligned with:

• Central Drugs Standard Control Organization (CDSCO – West Zone)

• Gujarat State Food & Drug Administration (Gujarat 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 Vapi-based manufacturers and exporters.

Our Core DMF Services – Vapi

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

We prepare complete, structured, and CDSCO-aligned DMF dossiers in CTD format accepted for:

• India
• USA (USDMF)
• EU (ASMF)
• GCC & MENA
• ASEAN
• Africa & LATAM

Applicant’s Part (Open Part) – Vapi

Prepared for submission to CDSCO / Gujarat 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 – Hot & Humid)

✅ Confidential data is accessed only by regulatory authorities and never disclosed to applicants.

DMF Types Covered – Vapi

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

🧪 DMF Review & Gap Assessment – Vapi

Already have a DMF prepared in Vapi?

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

• CDSCO West Zone & Gujarat 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 & Gujarat FDA Submission Support – Vapi

We provide hands-on regulatory support, including:

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

We ensure:

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

🧪 DMF Lifecycle Management & Maintenance – Vapi

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 – Vapi

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

• CDSCO deficiency letters & Gujarat 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 Vapi?

🧪 Strong experience with Vapi GIDC pharma & chemical manufacturing clusters
🧪 Deep working exposure with Gujarat FDA & CDSCO West Zone
🧪 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 – Vapi

• API manufacturers
• Bulk drug & chemical-pharma companies
• Finished formulation (FDF) manufacturers
• Nutraceutical & herbal product manufacturers
• Excipient & packaging suppliers
• Exporters & importers
• Contract Manufacturing Organizations (CMOs)

Regulatory Standards Followed – Vapi

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

Your Trusted DMF Partner in Vapi

Whether you are an API manufacturer in Vapi GIDC, a bulk drug producer in Char Rasta area, a formulation unit near Daman border, or an exporter operating across South Gujarat, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions from Vapi to global markets.

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

If you want, I can also prepare:

✅ SEO landing page for “DMF Services in Vapi”
✅ South Gujarat pharma-focused brochure version
✅ Export-focused DMF services page for Vapi-based manufacturers & exporters