Analytical Method Validation Services – Oman

Ensuring Accuracy. Compliance. Regulatory Confidence for Oman 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 Oman regulatory requirements.

We support pharmaceutical manufacturers, API suppliers, local agents, Marketing Authorization Holders (MAHs), CMOs, and export-oriented companies targeting Oman with Ministry of Health (MOH) Oman–compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Oman MOH queries for product registration, import authorization, renewals, and lifecycle management.

Our Core Expertise – Oman Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Directorate General of Pharmaceutical Affairs & Drug Control (DGPADC), Ministry of Health, Oman, aligned with GCC Guidelines, ICH, and international pharmacopoeias.

✅ Assay Method Validation

• Potency and content determination for APIs & finished products
• Validation in accordance with ICH Q2 (R1 / R2) accepted by Oman MOH
• Accuracy, precision, linearity, range, robustness, and specificity
• USP / BP / Ph. Eur. / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances, degradation products, and process impurities
• Identification, qualification, and quantification of impurities
• Stability-indicating method validation as per Oman MOH & GCC expectations
• Compliance with ICH Q3A / Q3B / Q3C / Q3D

✅ Dissolution Method Validation

• Immediate-release & modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition evaluation, and robustness studies
• Compliance with Oman MOH & GCC product registration requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C accepted by Oman MOH
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, precision, LOD & LOQ

Products Covered – Oman

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders)
✅ Liquid oral formulations
✅ Injectable formulations (sterile & non-sterile)
✅ Semi-solid dosage forms
✅ Modified-release & controlled-release products

Regulatory Compliance – Oman

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Oman Ministry of Health (DGPADC) Regulations
• GCC Unified Drug Registration Guidelines
• ICH Q3A / Q3B / Q3C / Q3D
• WHO-GMP / EU-GMP / US FDA GMP (accepted for imports)

Post-Submission Regulatory Support – Oman

VALIDEX provides complete Oman MOH regulatory query management, including:

✅ Responses to MOH / DGPADC deficiency letters
✅ Scientific justification for analytical & validation parameters
✅ Data gap assessment & corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during MOH technical reviews & inspections

Why Choose VALIDEX for Oman?

✔ Strong understanding of Oman MOH & GCC regulatory expectations
✔ ICH-aligned, Gulf-focused documentation strategy
✔ Inspection-ready and audit-compliant validation reports
✔ Experience supporting imported medicines & API registrations
✔ Fast turnaround timelines
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Oman

• Oman-compliant Analytical Method Validation Protocols
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / GCC-CTD analytical summaries
• Oman MOH regulatory query response packages
• Method transfer, verification & re-validation documentation

Industries We Serve – Oman

• Pharmaceutical manufacturers exporting to Oman
• API manufacturers
• Local agents & Marketing Authorization Holders (MAHs)
• Contract Manufacturing Organizations (CMOs)
• Regional distributors
• Regulatory & dossier consulting firms

Import & GCC Market Support – Oman

VALIDEX supports Analytical Method Validation for:

• Oman MOH product registration
• GCC centralized & national procedures
• New registrations, renewals & variations
• Export dossiers prepared for Oman from India, EU, US & ASEAN

Partner with VALIDEX – Oman

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