Analytical Method Validation Services – Turkmenistan

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

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

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Ministry of Health and Medical Industry of Turkmenistan.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by Turkmenistan health authorities
• Accuracy, precision, linearity, robustness, and specificity
• USP / BP / Ph. Eur. / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with MoHMI & 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 Turkmenistan product registration and variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Turkmenistan

✅ 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 – Turkmenistan

All Analytical Method Validation activities are conducted in accordance with:

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

Post-Submission Regulatory Support – Turkmenistan

VALIDEX provides complete regulatory query management, including:

✅ Responses to MoHMI 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 dossier reviews, inspections, and audits

Why Choose VALIDEX for Turkmenistan?

✔ Strong understanding of Turkmenistan 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 – Turkmenistan

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

Industries We Serve in Turkmenistan

• 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 – Turkmenistan

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Turkmenistan

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