Analytical Method Validation Services – Ethiopia

Ensuring Accuracy. Compliance. Regulatory Confidence for Ethiopia 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 Ethiopian regulatory requirements.

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

Our Core Expertise – Ethiopia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Ethiopian Food and Drug Authority (EFDA) under the Ministry of Health, Federal Democratic Republic of Ethiopia.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Ethiopia

✅ 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 – Ethiopia

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• EFDA Registration Guidelines & Technical Requirements
• Ethiopian Food and Drug Administration Proclamation No. 1112/2019
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by EFDA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Ethiopia

VALIDEX provides complete EFDA query management, including:

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

Why Choose VALIDEX for Ethiopia?

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

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

Industries We Serve in Ethiopia

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

National & Export Support – Ethiopia

VALIDEX supports Analytical Method Validation for:

• Ethiopia domestic product registration (EFDA)
• Manufacturing and import license applications
• Export dossiers prepared for EFDA-regulated and WHO-referenced markets

Partner with VALIDEX – Ethiopia

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