Analytical Method Validation Services – Saudi Arabia

Ensuring Accuracy. Compliance. Regulatory Confidence for Saudi 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 Saudi Arabian regulatory requirements.

We support pharmaceutical manufacturers, MAHs, importers, and exporters targeting Saudi Arabia with SFDA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of SFDA queries for product registration, marketing authorization (MA), manufacturing/import licenses, and export dossiers.

Our Core Expertise – Saudi Arabia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Saudi Food & Drug Authority (SFDA) under the Drug Sector – Pharmaceutical Products.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by SFDA Saudi Arabia
• 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 SFDA & ICH expectations
• Compliance with ICH Q3A / Q3B and pharmacopoeial 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 SFDA product registration and post-approval requirements

✅ Residual Solvents Method Validation

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

Products Covered – Saudi Arabia

✅ 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 – Saudi Arabia

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• SFDA Drug Sector Guidelines & Requirements
• Saudi Food & Drug Law and Implementing Regulations
• GCC Guidelines for Pharmaceutical Products
• WHO-GMP Guidelines (as recognized by SFDA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Saudi Arabia

VALIDEX provides complete SFDA query management, including:

✅ Responses to SFDA deficiency letters and technical queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during SFDA inspections, audits, and dossier evaluations

Why Choose VALIDEX for Saudi Arabia?

✔ Strong understanding of SFDA & GCC regulatory expectations
✔ ICH-aligned, SFDA-focused documentation
✔ 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 – Saudi Arabia

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

Industries We Serve in Saudi Arabia

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

National & Export Support – Saudi Arabia

VALIDEX supports Analytical Method Validation for:

• Saudi Arabia product registration & MA approvals (SFDA)
• Manufacturing and import license support
• Export dossiers prepared for SFDA-regulated and GCC markets

Partner with VALIDEX – Saudi Arabia

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