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

DMF Direct, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Drug Master File (DMF) services for pharmaceutical manufacturers worldwide.
We specialize in the preparation, review, submission, and lifecycle management of Drug Master Files, including both:

1. Open Part (Applicant’s Part)

2. Closed Part (Restricted / Confidential Part)

Our services are designed to fully comply with US FDA, global MOH authorities, ICH, and CTD requirements, ensuring your DMF is submission-ready, regulator-friendly, and query-resistant.

Our Core DMF Services

🧪 DMF Preparation – Open & Closed Parts

We prepare complete, well-structured Drug Master Files in CTD format with full regulatory alignment.

Applicant’s Part (Open Part)

• Quality summaries and non-confidential information

• ANDA / NDA / MAA cross-reference-ready content

• Authority-compliant structure for applicants and regulators

Restricted Part (Closed Part)

• Confidential manufacturing process details

• Raw material, in-process, and finished product specifications

• Analytical methods, validations, and control strategies

• Proprietary information securely protected

DMF Types Covered

• Type II – Drug Substance, Drug Product, Intermediates

• Type III – Packaging Materials

• Type IV – Excipients

• Type V – Reference Information

🧪 DMF Review & Gap Assessment

Already have a DMF?
Our expert review services help identify and eliminate regulatory risks before submission.

We assess:

• Regulatory gaps vs FDA / MOH expectations

• CTD structural and content deficiencies

• Manufacturing, control, and stability inconsistencies

• Potential query-trigger points

✔️ You receive a clear, actionable gap assessment report before submission.

🧪 Global DMF Submission Support

We support DMF submissions and filings with:

• US FDA

• Ministry of Health (MOH) authorities worldwide

• WHO-aligned regulatory agencies

Our team ensures accurate formatting, correct referencing, and full compliance with authority-specific DMF guidelines.

🧪 DMF Lifecycle Management & Maintenance

We support your DMF throughout its entire lifecycle, including:

• Initial DMF filing

• Annual updates

• Manufacturing site or process changes

• Stability updates

• Specification revisions

• DMF amendments and variations

🧪 Post-Submission Query Handling (FDA / MOH)

Complete post-submission regulatory support, including:

• FDA Information Requests (IRs)

• MOH deficiency letters

• Scientific and technical response drafting

• Updated Open & Closed Part submissions

• Regulatory authority communication coordination

🎯 Goal: Fast, accurate, approval-focused responses.

🧪 Why Choose DMF Direct?

🧪 Global DMF expertise across multiple regulatory jurisdictions
🧪 Secure handling of confidential and proprietary information
🧪 CTD-compliant, authority-aligned documentation
🧪 Strong FDA & MOH deficiency response experience
🧪 Seamless coordination with ANDA / NDA / MAA applicants
🧪 Backed by Zoesoe Exports Pvt Ltd

Industries We Support

• API manufacturers

• Finished dosage form manufacturers

• Excipient manufacturers

• Packaging material suppliers

• Export-oriented pharmaceutical companies

Regulatory Standards We Follow

• US FDA DMF Guidance

• ICH Guidelines (Q-series, M-series)

• CTD & eCTD structure

• WHO Technical Reports

• Country-specific MOH requirements

Your Trusted Partner for DMF Excellence

Whether you are filing a new DMF, updating an existing DMF, or responding to regulatory queries, DMF Direct ensures your Drug Master File meets the highest global regulatory standards — securely, efficiently, and accurately.

“Where DMFs Meet Global Regulatory Standards.”

Excellence in DMF Research & Compliance.

Frequently Asked Questions (FAQs) – DMF Direct

1. What is a Drug Master File (DMF)?

A Drug Master File (DMF) is a confidential regulatory document submitted to authorities such as the US FDA or global Ministries of Health (MOH). It contains detailed information on manufacturing facilities, processes, quality controls, specifications, and stability for APIs, excipients, packaging materials, or reference data. DMFs support ANDA, NDA, MAA, or other regulatory submissions.

2. What DMF services does DMF Direct provide?

DMF Direct provides end-to-end DMF services, including:

• DMF preparation (Open & Closed Parts)

• DMF review and gap assessment

• Global DMF submission support

• DMF lifecycle management and annual updates

• DMF amendments and variations

• FDA and MOH post-submission query handling

3. What is the difference between Open Part and Closed Part of a DMF?

• Open Part (Applicant’s Part): Contains non-confidential information shared with ANDA/NDA/MAA applicants.

• Closed Part (Restricted Part): Contains proprietary and confidential information such as manufacturing processes, formulations, validations, and control strategies, submitted directly to regulators and kept confidential.

DMF Direct prepares both parts with strict confidentiality and regulatory compliance.

4. Which types of DMFs does DMF Direct handle?

We support preparation and management of:

• Type II DMF: Drug Substance, Drug Product, Intermediates

• Type III DMF: Packaging Materials

• Type IV DMF: Excipients

• Type V DMF: Reference Information

5. Which regulatory authorities do you support for DMF submission?

DMF Direct supports submissions to:

• US FDA

• Global MOH authorities

• WHO-aligned regulatory agencies

We follow authority-specific formats, guidelines, and technical expectations.

6. Do you provide DMF review and gap assessment services?

Yes. If you already have a DMF, our experts perform a detailed regulatory and technical gap assessment to identify:

• FDA / MOH compliance gaps

• CTD structure issues

• Data inconsistencies

• High-risk sections likely to trigger queries

A clear corrective action report is provided before submission.

7. Can DMF Direct handle FDA and MOH deficiency letters?

Absolutely. We provide complete post-submission support, including:

• FDA Information Requests (IRs)

• MOH deficiency letters

• Scientific and technical response drafting

• Revised Open & Closed Part submissions

• Regulatory communication coordination

Our focus is fast, accurate, and approval-oriented responses.

8. Do you manage DMF updates and lifecycle maintenance?

Yes. We support the entire DMF lifecycle, including:

• Annual updates

• Change control submissions

• Manufacturing site or process changes

• Stability data updates

• Specification revisions

• DMF amendments and variations

9. How does DMF Direct ensure confidentiality of proprietary information?

DMF Direct follows strict confidentiality protocols. Restricted information is maintained only in the Closed Part, securely handled, and shared exclusively with regulatory authorities. We ensure complete protection of intellectual property and trade secrets.

10. Do you coordinate with ANDA / NDA / MAA applicants?

Yes. We work closely with ANDA, NDA, and MAA applicants, ensuring proper referencing, Letter of Authorization (LoA) support, and seamless regulatory coordination.

11. Which regulatory standards and guidelines do you follow?

Our DMF documentation complies with:

• US FDA DMF Guidance

• ICH Guidelines (Q-Series, M-Series)

• CTD & eCTD formats

• WHO Technical Reports

• Country-specific MOH requirements

12. Which industries can benefit from DMF Direct services?

Our services are ideal for:

• API manufacturers

• Finished dosage form manufacturers

• Excipient manufacturers

• Packaging material suppliers

• Export-oriented pharmaceutical companies

13. Why should we choose DMF Direct?

DMF Direct offers:

• Global DMF regulatory expertise

• CTD-compliant, regulator-friendly documentation

• Strong FDA and MOH query response experience

• Secure handling of confidential data

• Backing of Zoesoe Exports Pvt Ltd, a trusted regulatory partner

14. How can we get started with DMF Direct?

You can contact DMF Direct for:

• New DMF preparation

• DMF review or gap assessment

• DMF submission or updates

• Post-submission regulatory support

Our team will guide you through the entire process.