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

CDSCO West Zone & Goa 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 manufacturers, formulation units, API traders, exporters, and nutraceutical companies based in Panaji and across Goa.

Our DMF services are fully aligned with:

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

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

Our Core DMF Services – Panaji (Goa)

🧪 DMF Preparation – Open & Closed Parts (India & Goa–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) – Panaji

Prepared for submission to CDSCO / Goa 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 – Panaji (Goa)

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

🧪 DMF Review & Gap Assessment – Panaji (Goa)

Already have a DMF prepared in Goa?

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

• CDSCO West Zone & Goa 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 & Goa FDA Submission Support – Panaji

We provide hands-on regulatory support, including:

• CDSCO submissions & technical justifications
• Goa 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 – Panaji (Goa)

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 – Panaji (Goa)

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

• CDSCO deficiency letters & Goa 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 Panaji (Goa)?

🧪 Strong experience with Goa pharma & nutraceutical manufacturing clusters
🧪 Deep working exposure with Goa 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 – Panaji (Goa)

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

Regulatory Standards Followed – Panaji (Goa)

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

Your Trusted DMF Partner in Panaji (Goa)

Whether you are a formulation unit in Verna Industrial Estate, an API trader in Vasco, a nutraceutical company in Ponda, or an exporter based in Panaji, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions from Goa to global markets.

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

If you want, I can also prepare:

✅ SEO landing page for “DMF Services in Goa / Panaji”
✅ Goa pharma-focused brochure version
✅ Export-focused DMF services page for Goa-based manufacturers & exporters