Drug Master File (DMF) / API Technical File Preparation, Review & Regulatory Support Services – China

DMF Direct, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Drug Master File (DMF) preparation, review, submission, and regulatory support services for pharmaceutical manufacturers exporting to China and global pharmaceutical markets.

We specialize in preparing regulatory-compliant Drug Master Files and technical documentation aligned with:

• National Medical Products Administration (NMPA), China

• Center for Drug Evaluation (CDE) requirements

• Chinese pharmaceutical regulatory expectations

• WHO recommendations

• ICH and CTD standards

Our services include complete support for:

• Open Part (Applicant’s Part)

• Closed Part (Restricted / Confidential Part)

We ensure your DMF documentation is technically accurate, submission-ready, regulator-friendly, and aligned with pharmaceutical registration expectations in China.

Our Core DMF Services for China

DMF Preparation – Open & Closed Parts

We prepare professionally structured Drug Master Files in CTD format suitable for pharmaceutical product registration and API filing support in China.

Applicant’s Part (Open Part)

• Non-confidential quality documentation

• Product and manufacturing summaries

• Applicant-reference-ready technical information

• Authority-aligned CTD structure

Restricted Part (Closed Part)

• Confidential manufacturing process information

• Raw material and finished product specifications

• Analytical methods and validation data

• Proprietary technical and control information

DMF Types Covered

• Active Pharmaceutical Ingredients (APIs)

• Drug Products

• Pharmaceutical Intermediates

• Excipients

• Packaging Materials

• Reference Information

DMF Review & Gap Assessment

Already have a DMF or technical dossier?

Our regulatory experts perform detailed scientific and regulatory assessments to identify potential deficiencies before submission in China.

We assess:

• Compliance gaps versus NMPA and CDE expectations

• CTD structure and formatting deficiencies

• Manufacturing and stability documentation gaps

• Analytical and specification inconsistencies

• Potential regulatory query-trigger points

✔️ You receive a detailed and actionable regulatory gap assessment report.

China Regulatory Submission Support

We support pharmaceutical manufacturers and exporters with:

• DMF preparation and filing support

• CTD technical dossier documentation

• API registration support documentation

• Excipient and packaging material documentation

• Regulatory correspondence assistance

Our team ensures proper documentation structure, technical consistency, and alignment with China pharmaceutical authority expectations.

DMF Lifecycle Management & Maintenance

We provide ongoing support throughout the complete DMF lifecycle, including:

• Initial DMF preparation

• Annual updates

• Manufacturing site or process modifications

• Stability updates

• Specification revisions

• Amendments and change control documentation

Post-Submission Query Handling Support

We provide scientific and technical support for responding to authority queries and deficiency observations, including:

• NMPA/CDE query response drafting

• Technical clarification preparation

• Updated Open & Closed Part documentation

• Scientific justifications and supporting data

• Regulatory communication coordination

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

Why Choose DMF Direct?

• Expertise in China and global pharmaceutical regulatory documentation

• Strong understanding of NMPA, CDE, WHO, CTD, and international regulatory requirements

• Secure handling of confidential manufacturing information

• Scientifically robust and regulator-focused documentation

• Experience supporting API and formulation exporters

• 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 affairs and dossier consultancy companies

Regulatory Standards We Follow

• NMPA and CDE regulatory requirements

• WHO Technical Report Series (TRS)

• ICH Guidelines (Q-series & M-series)

• CTD & eCTD structures

• International pharmaceutical quality standards

Your Trusted Partner for Pharmaceutical Regulatory Success in China

Whether you are preparing a new Drug Master File, updating existing technical documentation, supporting pharmaceutical product registration, or responding to regulatory authority queries, DMF Direct provides reliable, confidential, and globally aligned regulatory support services for the China pharmaceutical market.