Analytical Method Validation Services – Libya

Ensuring Accuracy. Compliance. Regulatory Confidence for Libya 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 Libyan regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Libya with Libyan MoH–compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of regulatory queries for product registration, import authorization, manufacturing approvals, and export dossiers.

Our Core Expertise – Libya Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Libyan Ministry of Health (MoH) through the General Administration of Pharmaceutical Affairs / Drug Control authorities.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by Libyan health authorities
• 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 Libyan product registration and variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Libya

✅ 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 – Libya

All Analytical Method Validation activities are conducted in accordance with:

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

Post-Submission Regulatory Support – Libya

VALIDEX provides complete Libyan MoH query management, including:

✅ Responses to MoH deficiency letters and technical evaluation 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 Libya?

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

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

Industries We Serve in Libya

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

National & Export Support – Libya

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Libya

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