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

CDSCO & Karnataka 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 and manufacturers based in Bangalore (Bengaluru), Karnataka.

Our DMF services are fully aligned with the regulatory requirements of:

• Central Drugs Standard Control Organization (CDSCO) – India

• Karnataka State Food & Drug Administration (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 and technology transfer filings

We specialize in preparation and maintenance of both:

1. Open Part (Applicant’s Part)

2. Closed Part (Restricted / Confidential Part)

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

Our Core DMF Services – Bangalore

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

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

Applicant’s Part (Open Part)

Prepared for submission to CDSCO / Karnataka 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 / 41)
– Manufacturing License (Form 25 / 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 regulatory authorities, never disclosed to applicants.

DMF Types Covered – Bangalore

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

🧪 DMF Review & Gap Assessment – Bangalore

Already have a DMF prepared in Bangalore?

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

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

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

🧪 CDSCO & Karnataka FDA Submission Support – Bangalore

We provide hands-on local regulatory support, including:

• CDSCO submissions & technical justifications
• Karnataka FDA manufacturing license support
• API registration & technical file support
• Import export regulatory documentation
• Global submission DMF alignment (USA, EU, GCC, ASEAN)

We ensure:

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

🧪 DMF Lifecycle Management & Maintenance – Bangalore

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 – Bangalore

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

• CDSCO deficiency letters & 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 Bangalore?

🧪 Strong experience with Bangalore-based pharma & biotech manufacturers
🧪 Deep knowledge of CDSCO & Karnataka 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 – Bangalore

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

Regulatory Standards Followed – Bangalore

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

Your Trusted DMF Partner in Bangalore

Whether you are a startup pharma unit in Peenya, an API manufacturer in Bommasandra, or an exporter in Whitefield, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions from Bangalore to global markets.

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

If you want, I can also create:

✅ SEO landing page for “DMF Services in Bangalore”
✅ Short brochure version for Karnataka manufacturers
✅ Export-focused DMF services page for Bangalore pharma exporters