Analytical Method Validation Services – Lebanon

Ensuring Accuracy. Compliance. Regulatory Confidence for Lebanon 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 Lebanese regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Lebanon with MoPH-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Ministry of Public Health (MoPH) queries for product registration, import authorization, and export dossiers.

Our Core Expertise – Lebanon Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the Ministry of Public Health (MoPH), Republic of Lebanon – Drug Directorate.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by MoPH Lebanon
• 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 MoPH 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 MoPH Lebanon product registration requirements

✅ Residual Solvents Method Validation

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

Products Covered – Lebanon

✅ 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 – Lebanon

All Analytical Method Validation activities are conducted in accordance with:

• Ministry of Public Health (MoPH), Lebanon guidelines
• Lebanese Pharmaceutical Registration Regulations
• Drug Directorate technical requirements
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP principles adopted by MoPH Lebanon
• Recognized pharmacopoeias (USP, BP, EP, IP)

Post-Submission Regulatory Support – Lebanon

VALIDEX provides complete MoPH Lebanon query management, including:

✅ Responses to MoPH 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 MoPH inspections, audits, and dossier evaluations

Why Choose VALIDEX for Lebanon?

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

Our Deliverables – Lebanon

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

Industries We Serve – Lebanon

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

National & Export Support – Lebanon

VALIDEX supports Analytical Method Validation for:

• Lebanon domestic product registration (MoPH)
• Import registration and marketing authorization
• Export dossiers prepared for submission to Lebanon
• Government tenders and institutional supply registrations

Partner with VALIDEX – Lebanon

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