Analytical Method Validation Services – Egypt

Ensuring Accuracy. Compliance. Regulatory Confidence for Egypt 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 Egyptian regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Egypt with EDA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Egyptian Drug Authority (EDA) queries for product registration, marketing authorization, manufacturing/import licensing, and export dossiers.

Our Core Expertise – Egypt Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Egyptian Drug Authority (EDA) under the Ministry of Health & Population, Arab Republic of Egypt.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by EDA Egypt
• 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 EDA, ICH & 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 EDA product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Egypt

✅ 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 – Egypt

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Egyptian Drug Authority (EDA) Registration Guidelines
• Egyptian Drug Law No. 151 of 2019 & Executive Regulations
• WHO Technical Report Series (TRS)
• WHO-GMP & EU-GMP Guidelines (recognized by EDA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Egypt

VALIDEX provides complete EDA query management, including:

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

Why Choose VALIDEX for Egypt?

✔ Strong understanding of EDA regulatory expectations
✔ ICH-aligned, WHO/EU-compliant documentation accepted in Egypt
✔ 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 – Egypt

• Analytical Method Validation Protocols (EDA-compliant)
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / eCTD Module 3 summaries for EDA submissions
• Regulatory query response packages
• Method transfer, verification, and re-validation documentation

Industries We Serve in Egypt

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

National & Export Support – Egypt

VALIDEX supports Analytical Method Validation for:

• Egypt domestic product registration (EDA)
• Manufacturing and import license applications
• Export dossiers prepared for EDA-regulated, MENA, and WHO-referenced markets

Partner with VALIDEX – Egypt

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