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

NMPA / CDE–Compliant BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies and Comparative Dissolution Profiling, designed fully in accordance with China’s regulatory expectations under the NMPA and CDE.

China requires BE studies for generic drug registration under its Generic Quality and Efficacy Consistency Evaluation Program, one of the most rigorous systems in Asia.

Our BE studies comply with:

• NMPA Guidelines for Bioequivalence Studies

• CDE Technical Requirements for Generic Drug Consistency Evaluation

• ICH Guidelines (E6 R2, E8 R1, Q2, Q6A, M10)

• China GCP (2020 Revision)

• China GLP & China GMP

• ChP (Chinese Pharmacopoeia) Dissolution Standards

• WHO & EMA BE scientific references where applicable

This ensures your BE study data meets China’s high standards and international harmonization requirements.

💊 Core BA/BE Services for China (NMPA/CDE-Aligned)

Clinical BA/BE Studies (Human)

• Conducted per NMPA/CDE requirements and China GCP (2020).
• Single-dose and multiple-dose BE studies using crossover/parallel designs.
• Healthy volunteer studies; patient-based PK for special formulations.
• Ethical approval via certified Institutional Review Boards (IRBs).
• Protocols fully aligned with NMPA BE guidelines & ICH E6 (R2).

Comparative Dissolution Profiling (CDP)

• Mandatory under China’s Generic Drug Consistency Evaluation.
• Dissolution performed as per ChP, USP, EP, and biorelevant media.
• Similarity factor f2, discrimination testing, and kinetic modeling.
• Supports both IR and MR formulations.

IVIVC & Biowaiver Support

• Based on CDE/ICH guidelines and WHO TRS where applicable.
• Level A/B/C IVIVC modeling for dissolution–PK predictability.
• BCS-based biowaiver justification for eligible APIs (primarily Class I).

Analytical Method Development & Validation

• LC-MS/MS and HPLC-UV method development tailored for Chinese regulatory standards.
• Validation per ICH M10 and CDE bioanalytical requirements.
• Stability-indicating assay development for APIs & finished products.
• Full validation: accuracy, precision, selectivity, linearity, recovery & stability.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK calculations (AUC, Cmax, Tmax, t½).
• NMPA/ICH-standard BE acceptance criteria: 90% CI within 80–125%.
• Scaled BE for Highly Variable Drugs (HVDs) accepted with justification.
• Sample-size & power analysis performed per CDE expectations.

📑 NMPA / CDE Submission-Ready Documentation

We prepare full submission documentation aligned to Chinese CTD requirements:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per ICH E3 + CDE format
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile (CDP) Report
• China-CTD Modules 1–5, including:

• Module 1: Chinese administrative & legal requirements

• Module 2–5: Full quality, nonclinical & clinical documentation

• Consistency Evaluation reports for generics

✨ Why Choose BioEquiGlobal for China?

• NMPA/CDE-Aligned Expertise: Ensures studies meet China’s highest regulatory standards.
• Designed for Consistency Evaluation: Supports China’s stringent generic drug quality reform.
• International Quality Systems: GCP/GLP/GMP-compliant processes ensure global acceptance.
• Ideal for China + Global Markets: Dossiers structured for China, USFDA, EMA, WHO PQ, GCC, TGA and more.
• Specialization in Complex BE: MR products, HVDs, injectables, ophthalmics, inhalation, topicals & peptide-based medicines.

🗺️ BA/BE Study Workflow for China (NMPA/CDE Submissions)

1. Feasibility & Chinese Regulatory Mapping
   (Reference product identification, BE pathway, biowaiver assessment)

2. NMPA-Aligned Protocol Development & IRB Approval
   (China GCP 2020 + ICH E6 compliant)

3. Analytical Method Development & Validation
   (ICH M10 + CDE bioanalytical requirements)

4. Clinical Study Execution
   (Volunteer recruitment, dosing, PK sampling under certified Chinese GCP standards)

5. NMPA & CDE–Compliant DMF / API Technical Documentation & Regulatory Support
   By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd

   DMF Direct provides end-to-end Drug Master File (DMF) / API Technical File preparation, review, submission, and lifecycle management services specifically tailored for China’s highly regulated pharmaceutical framework.

   ⚠️ China does not follow the traditional US/EU DMF system. Instead, API manufacturers must submit a Drug Substance Registration Dossier through the CDE under NMPA. We provide full China API technical file & linkage support equivalent to DMF/ASMF.

   Our services are designed to meet the expectations of:

   • NMPA – National Medical Products Administration, China

   • CDE – Center for Drug Evaluation, China

   And comply with:

   • China Drug Administration Law

   • NMPA Registration Regulations (Drug Registration Regulation – 2020)

   • China GMP

   • ICH Guidelines (China is ICH member)

   • China CTD (Module 1–5) format used for:

   • API registration & China Drug Master Record (DMR)
   • Finished pharmaceutical product (FPP) registration
   • Clinical Trial Application (CTA) support
   • Import drug registration
   • Marketing Authorization Holder (MAH) filings
   • China-linked global regulatory submissions

   We specialize in the preparation and maintenance of both:

   1. Open Part (Applicant / MAH / CDE-Linked Information)

   2. Confidential Part (Restricted Manufacturer’s Technical File)

   Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with NMPA & CDE.

   Our Core DMF / API Technical Services – China

   🧪 API / DMF Technical File Preparation – China-Compliant

   We prepare complete, structured, and China CTD-aligned API technical dossiers accepted by CDE for China drug registrations.

   Applicant’s / Open Part

   Prepared for submission to CDE / China MAHs, including:

   • China-format Quality Overall Summary (QOS)
   • Non-confidential API manufacturing & quality overview
   • Cross-reference-ready documentation for:
   – China MAH Drug Registration
   – Import Drug Applications
   – Clinical Trial Applications (CTA)
   • China CTD structured documentation for Module 2 & 3

   Restricted / Confidential Part

   Secure preparation and controlled handling of proprietary API technical data, including:

   • Detailed synthetic route & manufacturing process
   • Critical process parameters & in-process controls
   • Raw material & intermediate specifications
   • Drug substance specifications
   • Analytical methods & validation (ICH Q2 + ChP)
   • Control strategy & Pharmaceutical Quality System (PQS)
   • Stability data as per China climatic zone (Zone II / IVa depending on region)

   ✅ Confidential data is disclosed only to CDE reviewers — not to China MAHs or commercial applicants.

   DMF / API Technical File Types Covered – China

   We support China API / technical documentation for:

   • Chemical APIs (Small Molecules)
   • Biological APIs (with PEI-style comparability where required)
   • Excipients
   • Packaging Materials
   • Reference Standards & Miscellaneous Technical Data

   🧪 DMF / API Technical File Review & Gap Assessment – China

   Already have an API dossier for China?

   We conduct China-specific technical review & regulatory gap analysis based on:

   • CDE quality assessment expectations
   • China GMP compliance gaps
   • China CTD structure & data deficiencies
   • Process validation & impurity profile gaps
   • Stability non-compliance
   • Likely CDE deficiency triggers

   ✔️ You receive a clear, actionable China gap-assessment report before official CDE submission.

   🧪 NMPA / CDE Submission & China Regulatory Support

   We provide hands-on support for API technical filing & linkage in China, including:

   • CDE electronic dossier preparation
   • API registration linkage with MAH
   • Import drug technical support
   • CTA-linked API documentation
   • Technical translation (English ↔ Chinese) coordination
   • Regulatory strategy for domestic vs imported drugs

   Our team ensures:

   • Correct China CTD formatting
   • Accurate cross-referencing with MAH dossiers
   • Full consistency across API technical file, DMF-equivalent records & finished product applications

   🧪 DMF / API Technical File Lifecycle Management – China

   We manage your China API technical file throughout its entire regulatory lifecycle, including:

   • Initial API registration compilation
   • Change management & post-approval amendments
   • Manufacturing site changes
   • Process optimization & scale-up support
   • Stability updates
   • Specification & impurity profile revisions
   • CDE-driven variations & re-evaluations

   🧪 Post-Submission Deficiency & Query Handling – China

   Complete post-submission regulatory support, including:

   • CDE deficiency letters & technical questions
   • Scientific justification & response drafting
   • Revised confidential & open technical submissions
   • Alignment with China MAHs & agents
   • Coordination between manufacturer, MAH & CDE

   🎯 Goal: Faster API linkage, reduced review cycles, and CDE-ready technical documentation.

   🧪 Why Choose DMF Direct for China?

   🧪 In-depth expertise in NMPA & CDE regulatory systems
   🧪 Strong experience with China GMP & ICH-aligned API documentation
   🧪 Secure handling of confidential synthetic & process information
   🧪 Proven CDE deficiency response success
   🧪 Seamless coordination with China MAHs, CROs & regulatory agents
   🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength

   Industries We Support – China

   • API manufacturers (chemical & biological)
   • Finished formulation (FPP) manufacturers
   • Excipient manufacturers
   • Packaging material suppliers
   • China MAHs & importers
   • CROs & CDMOs
   • Export-focused pharma companies

   Regulatory Standards Followed – China

   • China Drug Administration Law
   • NMPA & CDE Technical Guidelines
   • China GMP
   • ICH Q-Series & M-Series Guidelines
   • China CTD / eCTD formats
   • Chinese Pharmacopoeia (ChP)
   • WHO-GMP (where applicable)

   Your Trusted Partner for DMF / API Technical Excellence in China

   Whether you are registering a new API in China, linking your drug substance to a China MAH, supporting an import drug application, or responding to CDE technical queries, DMF Direct delivers high-quality, compliant, and approval-focused API technical documentation for the Chinese pharmaceutical market.

   ✅ China regulatory–aligned
   ✅ Confidential
   ✅ Efficient
   ✅ Approval-driven

   If you want, I can also prepare:

   ✅ China–ASEAN (Singapore, Malaysia, Vietnam) regional API strategy version
   ✅ SEO landing page for “API DMF / Technical File Services for China”
   ✅ Export-focused China DMF services page for Indian API manufacturers

6. China-CTD Documentation Preparation
   (CSR, CDP, validation package & CTD Modules 1–5)

Who We Support in China & Internationally

• Chinese generic manufacturers undergoing Consistency Evaluation
• Global companies entering the China pharmaceutical market
• CROs in China needing BA/BE partnerships
• Export-oriented pharma targeting Asia
• R&D teams reformulating products for China
• Specialty pharma & biotech firms