Analytical Method Validation Services – Qatar

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

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

Our Core Expertise – Qatar Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Pharmacy & Drug Control Department (PDCD), Ministry of Public Health, Qatar, 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 Qatar MoPH
• 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 Qatar MoPH & 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 Qatar MoPH & GCC product registration requirements

✅ Residual Solvents Method Validation

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

Products Covered – Qatar

✅ 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 – Qatar

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Qatar Ministry of Public Health (PDCD) 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 – Qatar

VALIDEX provides complete Qatar MoPH regulatory query management, including:

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

Why Choose VALIDEX for Qatar?

✔ Strong understanding of Qatar MoPH & 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 – Qatar

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

Industries We Serve – Qatar

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

Import & GCC Market Support – Qatar

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Qatar

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