Analytical Method Validation Services – Kazakhstan

Ensuring Accuracy. Compliance. Regulatory Confidence for Kazakhstan & EAEU 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 Kazakhstan and EAEU regulatory requirements.

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

Our Core Expertise – Kazakhstan Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Committee for Medical and Pharmaceutical Control (CMPC) and conducted through the National Center for Expertise of Medicines and Medical Devices (NCEMMD).

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted under EAEU regulations
• 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 NCEMMD, EAEU & WHO expectations
• Compliance with ICH Q3A / Q3B, Q3D (elemental impurities) and pharmacopoeial 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 Kazakhstan / EAEU product registration and variation requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C as implemented in EAEU technical regulations
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, and precision

Products Covered – Kazakhstan

✅ 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 – Kazakhstan

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• EAEU Technical Regulations (TR EAEU 043/2017 & related acts)
• CMPC / NCEMMD Registration & Expertise Requirements
• Code of the Republic of Kazakhstan “On Public Health and Healthcare System”
• WHO Technical Report Series (TRS)
• WHO-GMP / EAEU-GMP Guidelines
• Ph. Eur. / USP / BP Pharmacopoeial Standards

Post-Submission Regulatory Support – Kazakhstan

VALIDEX provides complete CMPC / NCEMMD query management, including:

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

Why Choose VALIDEX for Kazakhstan?

✔ Strong understanding of Kazakhstan & EAEU regulatory expectations
✔ ICH-aligned, EAEU/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 – Kazakhstan

• Analytical Method Validation Protocols (Kazakhstan / EAEU-compliant)
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / EAEU dossier summaries
• Regulatory query response packages
• Method transfer, verification, and re-validation documentation

Industries We Serve in Kazakhstan

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

National & EAEU Export Support – Kazakhstan

VALIDEX supports Analytical Method Validation for:

• Kazakhstan domestic product registration (CMPC / NCEMMD)
• EAEU registrations (mutual recognition & decentralized procedures)
• Export dossiers prepared for Kazakhstan, EAEU, and WHO-referenced markets

Partner with VALIDEX – Kazakhstan

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