Analytical Method Validation Services – Uzbekistan

Ensuring Accuracy. Compliance. Regulatory Confidence for Uzbekistan 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 Uzbekistan regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Uzbekistan with CSP-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Center for Safety of Pharmaceuticals (CSP) queries for product registration, marketing authorization, manufacturing/import approvals, and export dossiers.

Our Core Expertise – Uzbekistan Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Center for Safety of Pharmaceuticals (CSP) under the Ministry of Health, Republic of Uzbekistan.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by CSP Uzbekistan
• Accuracy, precision, linearity, robustness, and specificity
• Ph. Eur. / USP / BP / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with CSP & WHO expectations
• Compliance with ICH Q3A / Q3B and pharmacopoeial impurity limits

✅ Dissolution Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Uzbekistan

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

Regulatory Compliance – Uzbekistan

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• CSP Drug Registration Guidelines & Technical Requirements
• Law of the Republic of Uzbekistan “On Medicines and Pharmaceutical Activities”
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by Uzbekistan
• Ph. Eur. / USP / BP Pharmacopoeial Standards

Post-Submission Regulatory Support – Uzbekistan

VALIDEX provides complete CSP query management, including:

✅ Responses to CSP deficiency letters and scientific evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during CSP dossier reviews, inspections, and audits

Why Choose VALIDEX for Uzbekistan?

✔ Strong understanding of Uzbekistan regulatory expectations
✔ ICH-aligned, WHO-compliant documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Uzbekistan

• Analytical Method Validation Protocols (CSP-compliant)
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / Non-CTD summary documents for CSP submissions
• Regulatory query response packages
• Method transfer, verification, and re-validation documentation

Industries We Serve in Uzbekistan

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

National & Export Support – Uzbekistan

VALIDEX supports Analytical Method Validation for:

• Uzbekistan domestic product registration (CSP)
• Manufacturing and import authorization applications
• Export dossiers prepared for Uzbekistan and WHO-referenced markets

Partner with VALIDEX – Uzbekistan

Achieve CSP-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Uzbekistan.