Analytical Method Validation Services – Syria

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

We support pharmaceutical manufacturers, local agents, importers, and exporters targeting Syria with Syrian MoH–compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Ministry of Health (MoH) queries for product registration, import approvals, manufacturing licensing, and export dossiers.

Our Core Expertise – Syria Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Syrian Ministry of Health (MoH) through the Directorate of Drug Control (DDC).

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by Syrian MoH
• 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 MoH & 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 Syrian product registration and variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Syria

✅ 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 – Syria

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Syrian Ministry of Health Drug Registration Guidelines
• Syrian Pharmaceutical Law & Executive Regulations
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (as referenced by Syrian MoH)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Syria

VALIDEX provides complete MoH / DDC query management, including:

✅ Responses to MoH deficiency letters and technical review queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during MoH dossier reviews, inspections, and audits

Why Choose VALIDEX for Syria?

✔ Strong understanding of Syrian MoH regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Syria
✔ 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 – Syria

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

Industries We Serve in Syria

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

National & Export Support – Syria

VALIDEX supports Analytical Method Validation for:

• Syrian domestic product registration (MoH)
• Import authorization and product approvals
• Export dossiers prepared for MoH-regulated and WHO-referenced markets

Partner with VALIDEX – Syria

Achieve Syrian MoH–ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Syria.