Analytical Method Validation Services – China

Ensuring Accuracy. Compliance. Regulatory Confidence for Chinese Regulatory Submissions

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, fully compliant with Chinese regulatory requirements.

We support API manufacturers, finished formulation companies, CMOs, CROs, and export-oriented pharmaceutical organizations targeting China with NMPA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of National Medical Products Administration (NMPA) queries for drug registration, import approval, DMF/API filings, and lifecycle management.

Our Core Expertise – China Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the National Medical Products Administration (NMPA) and aligned with Chinese Pharmacopoeia (ChP) and ICH guidelines adopted by China.

✅ Assay Method Validation

• Potency and content determination for APIs & finished products
• Validation in accordance with ICH Q2 (R1 / R2) as adopted by NMPA
• Accuracy, precision, linearity, range, robustness, and specificity
• ChP / USP / EP harmonized analytical methods with Chinese regulatory justification

✅ Impurities Method Validation

• Related substances, degradation products, and process impurities
• Identification, qualification, and quantification of impurities
• Stability-indicating method validation as per ChP & NMPA technical guidelines
• Compliance with ICH Q3A / Q3B / Q3C / Q3D accepted by NMPA

✅ Dissolution Method Validation

• Immediate-release & modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition evaluation, robustness studies
• Compliance with Chinese Pharmacopoeia (ChP) & NMPA drug registration requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C as adopted by NMPA
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, precision, LOD & LOQ

Products Covered – China

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders)
✅ Liquid oral formulations
✅ Injectable formulations (sterile & non-sterile)
✅ Semi-solid dosage forms
✅ Modified-release & controlled-release products

Regulatory Compliance – China

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2) (China ICH member)
• NMPA Drug Registration Regulations
• Chinese Pharmacopoeia (ChP)
• ICH Q3A / Q3B / Q3C / Q3D
• Good Manufacturing Practice (China GMP)
• WHO-GMP (where applicable for imports)

Post-Submission Regulatory Support – China

VALIDEX provides complete NMPA regulatory query management, including:

✅ Responses to NMPA deficiency letters
✅ Scientific justification for analytical and validation parameters
✅ Data gap assessment & corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during NMPA technical reviews & inspections

Why Choose VALIDEX for China?

✔ Strong understanding of NMPA technical review expectations
✔ ICH-aligned yet China-specific documentation strategy
✔ Inspection-ready and audit-compliant validation reports
✔ Experience supporting imported drugs, APIs & DMF-style filings
✔ Fast turnaround timelines
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – China

• China-compliant Analytical Method Validation Protocols
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / China CTD (C-CTD) analytical summaries
• NMPA regulatory query response packages
• Method transfer, verification & re-validation documentation

Industries We Serve – China

• API manufacturers supplying to China
• Finished formulation companies (imported drugs)
• Contract Manufacturing Organizations (CMOs)
• Contract Research Organizations (CROs)
• Multinational pharmaceutical companies
• Regulatory & dossier consulting firms

Import & Export Support – China

VALIDEX supports Analytical Method Validation for:

• NMPA drug registration (imported products)
• API registration & technical review support
• Lifecycle management & post-approval variations
• Export dossiers prepared for China from India, EU, US & ASEAN

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 for China.