🇦🇪 Analytical Method Validation Services – United Arab Emirates (UAE)

Ensuring Accuracy. Compliance. Regulatory Confidence for UAE 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 in full compliance with United Arab Emirates (UAE) regulatory requirements.

We support pharmaceutical manufacturers and suppliers across the UAE with Ministry of Health and Prevention (MOHAP)-compliant analytical validation, ICH-aligned documentation, and post-submission handling of MOHAP queries for drug registration, licensing, and import/export requirements.

🇦🇪 Our Core Expertise – UAE Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Ministry of Health and Prevention (MOHAP) and internationally recognized pharmacopoeias.

• ✅ Assay Method Validation

  • Potency and content determination

  • Validation as per ICH Q2 (R1 / R2) aligned with MOHAP expectations

  • Accuracy, precision, linearity, robustness, and specificity

  • USP/EP/BP harmonized methods

• ✅ Impurities Method Validation

  • Related substances & degradation product profiling

  • Identification and quantification of impurities

  • Stability-indicating method validation as per ICH and WHO-GMP

• ✅ Dissolution Method Validation

  • Immediate & modified release products

  • Discriminatory dissolution method development

  • Media selection, sink condition assessment, and method robustness

  • Compliance with MOHAP product registration requirements

• ✅ Residual Solvents Method Validation

  • Gas Chromatographic (GC) method validation

  • Compliance with ICH Q3C adopted by MOHAP

  • Class I, II & III residual solvents

  • Limits, system suitability, accuracy, and precision

🇦🇪 Products Covered – UAE

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules, sachets)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Modified & controlled release products

🇦🇪 Regulatory Compliance – UAE

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)

• MOHAP Guidelines and Federal Drug Law (No. 4 of 1983)

• WHO-GMP and relevant Gulf Cooperation Council (GCC) standards

• United States Pharmacopeia (USP)

• European Pharmacopoeia (EP)

• British Pharmacopoeia (BP)

🇦🇪 Post-Submission Regulatory Support (UAE)

VALIDEX provides complete MOHAP query management, including:

• ✅ Response to MOHAP deficiency letters

• ✅ Scientific justification for validation parameters

• ✅ Data gap assessment & corrective documentation

• ✅ Revised validation protocols and reports

• ✅ Technical support during regulatory inspections & audits

🇦🇪 Why Choose VALIDEX for UAE?

• ✔ Strong understanding of UAE MOHAP regulatory expectations

• ✔ ICH-aligned yet MOHAP-focused documentation

• ✔ Inspection-ready and audit-compliant validation reports

• ✔ Fast turnaround timelines

• ✔ Strict confidentiality & data integrity

• ✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

🇦🇪 Our Deliverables – UAE

• Analytical Method Validation Protocols (MOHAP-compliant)

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD / Non-CTD summary documents for MOHAP submissions

• Regulatory query response packages

• Method transfer & verification documentation

🇦🇪 Industries We Serve in UAE

• Pharmaceutical manufacturing companies

• API manufacturers and traders

• Generic formulation companies

• Contract Manufacturing Organizations (CMOs)

• Import and Distribution companies

• Regulatory & dossier consulting firms

🇦🇪 National & Export Support

VALIDEX supports Analytical Method Validation for:

• UAE domestic approvals (MOHAP registration)

• Manufacturing licenses & product permissions

• Export dossiers for shipment from the UAE