Analytical Method Validation Services – Azerbaijan

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

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

Our Core Expertise – Azerbaijan Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Analytical Expertise Center (AEC) under the Ministry of Health, Republic of Azerbaijan.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by AEC Azerbaijan
• Accuracy, precision, linearity, robustness, and specificity
• USP / BP / EP / IP harmonized analytical methods

✅ Impurities Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Azerbaijan

✅ 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 – Azerbaijan

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• AEC Drug Registration Guidelines & Technical Requirements
• Law on Medicines of the Republic of Azerbaijan
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by AEC)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Azerbaijan

VALIDEX provides complete AEC query management, including:

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

Why Choose VALIDEX for Azerbaijan?

✔ Strong understanding of AEC regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Azerbaijan
✔ 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 – Azerbaijan

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

Industries We Serve in Azerbaijan

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers, distributors, and MAHs
• Regulatory and dossier consulting firms

National & Export Support – Azerbaijan

VALIDEX supports Analytical Method Validation for:

• Azerbaijan domestic product registration (AEC)
• Manufacturing and import authorization applications
• Export dossiers prepared for AEC-regulated and WHO-referenced markets

Partner with VALIDEX – Azerbaijan

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