Analytical Method Validation Services – Yemen

Ensuring Accuracy. Compliance. Regulatory Confidence for Yemen 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 Yemeni regulatory requirements.

We support pharmaceutical manufacturers, local agents, importers, and exporters targeting Yemen with SBDMA-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 – Yemen Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Supreme Board of Drugs and Medical Appliances (SBDMA) under the Ministry of Public Health and Population (MoPHP), Republic of Yemen.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Yemen

✅ 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 – Yemen

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• SBDMA Drug Registration Guidelines & Technical Requirements
• Pharmacy Law No. 26 of 2002 (Yemen)
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by SBDMA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Yemen

VALIDEX provides complete SBDMA query management, including:

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

Why Choose VALIDEX for Yemen?

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

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

Industries We Serve in Yemen

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

National & Export Support – Yemen

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Yemen

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