Analytical Method Validation Services – Georgia

Ensuring Accuracy. Compliance. Regulatory Confidence for Georgia 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 Georgia’s regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Georgia with SRAMPA-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 – Georgia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the State Regulation Agency for Medical and Pharmaceutical Activities (SRAMPA) under the Ministry of Health, Georgia.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Georgia

✅ 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 – Georgia

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• SRAMPA Registration Guidelines & Technical Requirements
• Law of Georgia on Medicines and Pharmaceutical Activities
• WHO Technical Report Series (TRS)
• WHO-GMP / EU-GMP principles (recognized by Georgia)
• European Pharmacopoeia (Ph. Eur.) / USP / BP standards

Post-Submission Regulatory Support – Georgia

VALIDEX provides complete regulatory query management, including:

✅ Responses to SRAMPA 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 dossier reviews, inspections, and audits

Why Choose VALIDEX for Georgia?

✔ Strong understanding of Georgian & EU-aligned regulatory expectations
✔ ICH-aligned, WHO/EU-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 – Georgia

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

Industries We Serve in Georgia

• 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 – Georgia

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Georgia

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