Analytical Method Validation Services – Russia

Ensuring Accuracy. Compliance. Regulatory Confidence for Russia & 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 Russian Federation and EAEU regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Russia with MoH RF / SCEEMP-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 – Russia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Ministry of Health of the Russian Federation and conducted through the Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP), in accordance with EAEU procedures.

✅ 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 (where applicable under EAEU rules)

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with SCEEMP, 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 Russia / EAEU product registration and post-approval 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 – Russia

✅ 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 – Russia

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• EAEU Technical Regulations (TR EAEU 043/2017 & related acts)
• MoH RF & SCEEMP Registration and Expert Evaluation Requirements
• Federal Law No. 61-FZ “On Circulation of Medicines”
• WHO Technical Report Series (TRS)
• WHO-GMP / EAEU-GMP Guidelines
• State Pharmacopoeia of the Russian Federation / Ph. Eur. / USP standards

Post-Submission Regulatory Support – Russia

VALIDEX provides complete MoH RF / SCEEMP 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, GMP inspections, and regulatory audits

Why Choose VALIDEX for Russia?

✔ Strong understanding of Russian & 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 – Russia

• Analytical Method Validation Protocols (Russia / 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 Russia

• 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 – Russia

VALIDEX supports Analytical Method Validation for:

• Russia domestic product registration (MoH RF / SCEEMP)
• EAEU registrations (mutual recognition & decentralized procedures)
• Export dossiers prepared for Russia, EAEU, and WHO-referenced markets

Partner with VALIDEX – Russia

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