Regulatory And Research Services for Iraq
🇮🇶 Regulatory and Research Services for Iraq – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing comprehensive regulatory and research solutions for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Iraq market.
Our services ensure full compliance with the Iraq Ministry of Health (MOH), specifically the Directorate of Technical Affairs / Pharmacy and Drug Control (PDC), as well as ICH and WHO guidelines.
📘 Regulatory Services for Iraq
Regulatory & Product Registration Support – Iraq
We provide end-to-end assistance for pharmaceutical, nutraceutical, and cosmetic companies for dossier preparation, submission, and product approval in Iraq, ensuring smooth regulatory navigation and compliance with MOH/PDC requirements.
📘 Product Registration Services
• Preparation and submission of export registration dossiers for Rx and OTC products.
• Registration support for Herbal, Ayurveda, Nutraceutical, Veterinary, and Cosmetic products.
• Label and packaging compliance as per MOH Iraq labeling standards.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-formatted DMFs for APIs intended for Iraq submission.
• Preparation of quality, stability, and analytical sections as per MOH Iraq norms.
⚗️ Bioequivalence (BE) Study Support
• Design, coordination, and documentation of BE studies for MOH Iraq submission.
• Support for BE protocols, study reports, and CRO collaboration following WHO and MOH guidelines.
🔬 Analytical Method Validation (AMV) Services
• Analytical method validation as per ICH Q2(R2).
• Preparation of AMV protocols and reports for regulatory and internal quality use.
🧾 Regulatory Consultancy & Compliance
• Strategic regulatory guidance for entering the Iraq market.
• Assistance with import/export licensing, product registration renewals, and audits.
• Continuous updates on MOH Iraq regulatory framework and post-approval compliance.
🧪 Research & Development (R&D) Services – Iraq
Our R&D division provides technical, analytical, and formulation support aligned with MOH Iraq and international pharmaceutical quality standards.
💊 Formulation Development
• Development and optimization of oral, topical, and injectable formulations.
• Stability studies under Iraq’s climatic conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Method development and transfer to partner laboratories in compliance with MOH Iraq.
📑 Product Development Reports (PDRs)
• Comprehensive PDRs covering formulation, process, analytical, and stability data for submission to MOH Iraq.
🧍⚕️ Clinical Trial & Toxicology Support
• Clinical protocol preparation and data management for MOH Iraq submissions.
• Toxicology and safety evaluation in accordance with OECD and WHO principles.
🌏 Why Choose Us for the Iraq Market
• Experienced Team – Experts in MOH Iraq, ICH, and WHO frameworks.
• End-to-End Solutions – From dossier compilation to post-approval compliance.
• Regional Expertise – Proven success in MENA, ASEAN, and ROW markets.
• Efficient Documentation – Streamlined CTD/ACTD preparation ensuring quick approvals.
• Tailored Approach – Customized regulatory strategy per product and category.
📘 Regulatory & Dossier Documentation
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⚗️ Bioequivalence & Analytical Studies
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🧪 Technology Transfer & Safety
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