Analytical Method Validation Services – Ukraine

Ensuring Accuracy. Compliance. Regulatory Confidence for Ukraine 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 Ukrainian regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Ukraine with SMDC-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of State Service of Ukraine on Medicines and Drugs Control (SMDC) queries for product registration, marketing authorization, manufacturing/import approvals, and export dossiers.

Our Core Expertise – Ukraine Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the State Service of Ukraine on Medicines and Drugs Control (SMDC) under the Ministry of Health of Ukraine.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by SMDC Ukraine
• 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 SMDC, EU & 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 Ukrainian product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Ukraine

✅ 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 – Ukraine

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• SMDC Registration & Expertise Requirements
• Law of Ukraine “On Medicines”
• EU Directive 2001/83/EC (harmonized elements)
• WHO Technical Report Series (TRS)
• EU-GMP / WHO-GMP principles recognized by Ukraine
• European Pharmacopoeia (Ph. Eur.) / USP / BP standards

Post-Submission Regulatory Support – Ukraine

VALIDEX provides complete SMDC query management, including:

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

Why Choose VALIDEX for Ukraine?

✔ Strong understanding of Ukrainian & EU-aligned regulatory expectations
✔ ICH-aligned, EU/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 – Ukraine

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

Industries We Serve in Ukraine

• 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 – Ukraine

VALIDEX supports Analytical Method Validation for:

• Ukraine domestic product registration (SMDC)
• Manufacturing and import authorization applications
• Export dossiers prepared for Ukraine, EU-aligned, and WHO-referenced markets

Partner with VALIDEX – Ukraine

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