Analytical Method Validation Services – Tajikistan

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

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

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Agency for Medicines and Medical Devices (AMMD) under the Ministry of Health and Social Protection of the Population, Republic of Tajikistan.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Tajikistan

✅ 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 – Tajikistan

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• AMMD Drug Registration Guidelines & Technical Requirements
• Law of the Republic of Tajikistan on Medicines and Pharmaceutical Activities
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by Tajikistan
• Ph. Eur. / USP / BP Pharmacopoeial Standards

Post-Submission Regulatory Support – Tajikistan

VALIDEX provides complete AMMD query management, including:

✅ Responses to AMMD 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 AMMD dossier reviews, inspections, and audits

Why Choose VALIDEX for Tajikistan?

✔ Strong understanding of Tajikistan regulatory expectations
✔ ICH-aligned, 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 – Tajikistan

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

Industries We Serve in Tajikistan

• 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 – Tajikistan

VALIDEX supports Analytical Method Validation for:

• Tajikistan domestic product registration (AMMD)
• Manufacturing and import authorization applications
• Export dossiers prepared for Tajikistan and WHO-referenced markets

Partner with VALIDEX – Tajikistan

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