Analytical Method Validation Services – Belarus

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

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

Our Core Expertise – Belarus Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Ministry of Health of the Republic of Belarus and conducted through the Center for Expertise and Testing in Healthcare (CEETH).

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by Belarus health authorities
• 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 CEETH, EAEU & 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 Belarus / EAEU product registration and variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Belarus

✅ 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 – Belarus

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Belarus MoH Registration & Expertise Requirements
• EAEU Technical Regulations (TR EAEU 043/2017 & related acts)
• Law on Medicines of the Republic of Belarus
• WHO Technical Report Series (TRS)
• WHO-GMP / EAEU-GMP Guidelines
• Ph. Eur. / USP / BP Pharmacopoeial Standards

Post-Submission Regulatory Support – Belarus

VALIDEX provides complete CEETH / MoH 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 Belarus?

✔ Strong understanding of Belarus & 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 – Belarus

• Analytical Method Validation Protocols (Belarus / 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 Belarus

• 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 – Belarus

VALIDEX supports Analytical Method Validation for:

• Belarus domestic product registration (MoH / CEETH)
• EAEU registrations (mutual recognition procedures)
• Export dossiers prepared for Belarus, EAEU, and WHO-referenced markets

Partner with VALIDEX – Belarus

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