Analytical Method Validation Services – Iraq

Ensuring Accuracy. Compliance. Regulatory Confidence for Iraq 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 Iraqi regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Iraq with MOH-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Iraqi Ministry of Health (MOH) / State Company for Marketing Drugs and Medical Appliances (KIMADIA) queries for product registration, import approval, and export dossiers.

Our Core Expertise – Iraq Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the Iraqi Ministry of Health (MOH) and KIMADIA.

✅ Assay Method Validation

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

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of process- and degradation-related impurities
• Stability-indicating method validation aligned with Iraqi MOH and ICH expectations

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with Iraq product registration requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C accepted by Iraqi authorities
• Class I, II, and III residual solvents
• Limit justification, system suitability, accuracy, and precision

Products Covered – Iraq

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders, sachets)
✅ Injectable formulations (sterile and non-sterile)
✅ Semi-solid and liquid dosage forms
✅ Modified-release and controlled-release products

Regulatory Compliance – Iraq

All Analytical Method Validation activities are conducted in accordance with:

• Iraqi Ministry of Health (MOH) guidelines
• KIMADIA pharmaceutical registration requirements
• National Drug Registration Regulations of Iraq
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP principles accepted by Iraqi authorities
• Recognized pharmacopoeias (USP, BP, EP, IP)

Post-Submission Regulatory Support – Iraq

VALIDEX provides complete Iraq regulatory query management, including:

✅ Responses to MOH / KIMADIA deficiency letters and review comments
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and validation reports
✅ Technical support during MOH inspections, audits, and dossier evaluations

Why Choose VALIDEX for Iraq?

✔ Strong understanding of Iraqi MOH & KIMADIA regulatory expectations
✔ ICH-aligned, Iraq-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Efficient timelines for Iraq registration projects
✔ Strict confidentiality and data integrity compliance
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Iraq

• Analytical Method Validation Protocols (Iraq-compliant)
• Validation Reports for:
– Assay
– Impurities
– Dissolution
– Residual Solvents
• Dossier summaries for MOH / KIMADIA submissions
• Regulatory query response packages
• Method transfer, verification, and analytical bridging documentation

Industries We Serve – Iraq

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Export-oriented pharmaceutical units
• Regulatory and dossier consulting firms

National & Export Support – Iraq

VALIDEX supports Analytical Method Validation for:

• Iraq domestic product registration (MOH / KIMADIA)
• Import registration and marketing authorization
• Export dossiers prepared for submission to Iraq
• Government tenders and public sector supply registrations

Partner with VALIDEX – Iraq

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