Analytical Method Validation Services – Hong Kong

Ensuring Accuracy. Compliance. Regulatory Confidence for Hong Kong 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 Hong Kong regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Hong Kong with Department of Health (Drug Office)-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of regulatory queries for product registration, import licensing, and export dossiers.

Our Core Expertise – Hong Kong Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the Drug Office, Department of Health, Hong Kong SAR Government.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by Hong Kong authorities
• Accuracy, precision, linearity, robustness, and specificity
• Harmonized analytical methods as per BP / USP / EP / IP

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of process- and degradation-related impurities
• Stability-indicating method validation aligned with ICH and Hong Kong Drug Office expectations

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with Hong Kong product registration requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C accepted by Hong Kong authorities
• Class I, II, and III residual solvents
• Limit justification, system suitability, accuracy, and precision

Products Covered – Hong Kong

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

Regulatory Compliance – Hong Kong

All Analytical Method Validation activities are conducted in accordance with:

• Drug Office, Department of Health (Hong Kong) guidelines
• Pharmacy and Poisons Ordinance (Cap. 138) and subsidiary regulations
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP / PIC/S GMP principles accepted in Hong Kong
• Recognized pharmacopoeias (BP, USP, EP, IP)

Post-Submission Regulatory Support – Hong Kong

VALIDEX provides complete Hong Kong regulatory query management, including:

✅ Responses to Drug Office deficiency letters and review comments
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and validation reports
✅ Technical support during regulatory inspections, audits, and dossier evaluations

Why Choose VALIDEX for Hong Kong?

✔ Strong understanding of Hong Kong Drug Office regulatory expectations
✔ ICH-aligned, Hong Kong-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Efficient timelines for Hong Kong registration projects
✔ Strict confidentiality and data integrity compliance
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Hong Kong

• Analytical Method Validation Protocols (Hong Kong-compliant)
• Validation Reports for:
– Assay
– Impurities
– Dissolution
– Residual Solvents
• Dossier summaries for Hong Kong Drug Office submissions
• Regulatory query response packages
• Method transfer, verification, and analytical bridging documentation

Industries We Serve – Hong Kong

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers, distributors, and marketing authorization holders
• Regulatory and dossier consulting firms

National & Export Support – Hong Kong

VALIDEX supports Analytical Method Validation for:

• Hong Kong product registration (Drug Office, Department of Health)
• Import licensing and marketing authorization
• Export dossiers prepared for submission to Hong Kong
• International tender and institutional supply registrations

Partner with VALIDEX – Hong Kong

Achieve Hong Kong–ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Hong Kong.