🇨🇳 Analytical Method Validation Services – China

VALIDEX, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Analytical Method Validation (AMV) services for Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Finished Products in full compliance with China's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across China with compliance aligned with the National Medical Products Administration (NMPA), ICH-aligned documentation, and post-submission handling of NMPA queries for drug registration, licensing, and import/export requirements.

🇨🇳 Our Core Expertise – China Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the NMPA, specifically referencing the Chinese Pharmacopoeia (ChP) and NMPA technical guidelines, which are largely harmonized with ICH standards.

• ✅ Assay Method Validation (含量测定方法验证)

  • Potency and content determination

  • Validation strictly as per ICH Q2 (R1 / R2) aligned with NMPA and ChP expectations

  • Accuracy, precision, linearity, range, robustness, and specificity

  • ChP/USP/EP harmonized methods

• ✅ Impurities Method Validation (杂质检查方法验证)

  • Related substances & degradation product profiling

  • Identification and quantification of impurities

  • Stability-indicating method validation as per ICH Q3 and NMPA guidelines

• ✅ Dissolution Method Validation (溶出度方法验证)

  • Immediate & modified release products

  • Discriminatory dissolution method development

  • Media selection, sink condition assessment, and method robustness

  • Compliance with NMPA product registration requirements (CTD format).

• ✅ Residual Solvents Method Validation (残留溶剂方法验证)

  • Gas Chromatographic (GC) method validation

  • Compliance with ICH Q3C adopted by NMPA

  • Class I, II & III residual solvents

  • Limits, system suitability, accuracy, and precision

🇨🇳 Products Covered – China

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Modified & controlled release products

🇨🇳 Regulatory Compliance – China

All Analytical Method Validation activities are conducted in accordance with:

• NMPA Guidelines (including drug registration and technical requirements)

• ICH Q2 (R1 / R2) and other relevant ICH guidelines (China is an ICH Member)

• Chinese Pharmacopoeia (ChP) (2020 Edition)

• Good Manufacturing Practices (GMP) for Drugs (adopted by NMPA)

• Drug Administration Law of the People's Republic of China

🇨🇳 Post-Submission Regulatory Support (China)

VALIDEX provides complete regulatory query management, assisting with responses to NMPA queries and technical review requirements, including:

• ✅ Response to NMPA deficiency letters (often technical/CMC)

• ✅ Scientific justification for validation parameters

• ✅ Data gap assessment & corrective documentation

• ✅ Revised validation protocols and reports

• ✅ Technical support during NMPA inspections & audits

🇨🇳 Why Choose VALIDEX for China?

• ✔ Strong understanding of NMPA's specific technical review requirements and CTD structure.

• ✔ ICH-aligned documentation focused on Chinese national compliance norms, submitted in Mandarin Chinese (where applicable).

• ✔ Inspection-ready and audit-compliant validation reports.

• ✔ Fast turnaround timelines.

• ✔ Strict confidentiality & data integrity.

• ✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd.

🇨🇳 Our Deliverables – China

• Analytical Method Validation Protocols (NMPA-compliant)

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• Technical reports and summaries for NMPA submissions (often requiring Chinese translation/adaptation)

• Regulatory query response packages

• Method transfer & verification documentation

🇨🇳 Industries We Serve in China

• Pharmaceutical manufacturing companies

• API manufacturers and importers

• Generic formulation companies

• Contract Manufacturing Organizations (CMOs)

• Import and Distribution companies

• Regulatory & dossier consulting firms

🇨🇳 National & Export Support

VALIDEX supports Analytical Method Validation for:

• China domestic approvals (Drug Registration/Market Authorization from NMPA)

• Manufacturing licenses & product permissions

• Export dossiers from China

🇨🇳 Partner with VALIDEX – China

Achieve NMPA-ready analytical validation with confidence.

From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner in China.