Kuwait

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

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

Our Core Expertise – Kuwait Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Drug & Food Control Administration (DFCA), Ministry of Health, Kuwait, 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 Kuwait 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 GCC & Kuwait MOH 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 Kuwait MOH & GCC product registration requirements

✅ Residual Solvents Method Validation

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

Products Covered – Kuwait

✅ 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 – Kuwait

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Kuwait Ministry of Health (DFCA) 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 – Kuwait

VALIDEX provides complete Kuwait MOH regulatory query management, including:

✅ Responses to MOH / DFCA 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 Kuwait?

✔ Strong understanding of Kuwait 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 – Kuwait

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

Industries We Serve – Kuwait

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

Import & GCC Market Support – Kuwait

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Kuwait

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