Regulatory And Research Services for Lebanon
🇱🇧 Regulatory and Research Services for Lebanon – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing comprehensive regulatory and research support for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Lebanon market.
Our services ensure complete compliance with the Lebanese Ministry of Public Health (MOPH) – Pharmaceutical Department, as well as ICH and WHO guidelines.
📘 Regulatory Services for Lebanon
Regulatory & Product Registration Support – Lebanon
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with the MOPH Lebanon, ensuring smooth approval and market access.
📘 Product Registration Services
• Preparation and submission of registration dossiers for Rx and OTC products.
• Registration assistance for Herbal, Ayurveda, Nutraceutical, Veterinary, and Cosmetic products.
• Labeling and packaging guidance as per MOPH Lebanon regulatory requirements.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Lebanon.
• Preparation of quality, stability, and analytical documentation per MOPH and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies for products submitted to MOPH Lebanon.
• Development of BE study protocols and reports aligned with WHO and MOPH expectations.
🔬 Analytical Method Validation (AMV) Services
• Analytical method validation as per ICH Q2(R2) guidelines.
• Preparation of AMV documentation for submission and internal quality systems.
🧾 Regulatory Consultancy & Compliance
• Comprehensive regulatory consultancy for the Lebanon pharmaceutical market.
• Assistance with import licenses, MOPH inspections, renewals, and post-approval compliance.
• Ongoing updates on MOPH Lebanon regulatory developments to ensure continuous compliance.
🧪 Research & Development (R&D) Services – Lebanon
Our R&D team supports formulation development, analytical validation, and technical documentation as per MOPH and international standards.
💊 Formulation Development
• Development of oral, topical, and parenteral dosage forms.
• Optimization for efficacy, stability, and performance under Lebanese climatic conditions.
🧫 Analytical R&D Services
• Analytical method development and validation for assay, dissolution, and stability.
• Quality control and technical transfer of validated methods to partner facilities.
📑 Product Development Reports (PDRs)
• Preparation of detailed PDRs including manufacturing, QC, and stability data.
• Submission-ready documentation compliant with MOPH Lebanon guidelines.
🧍⚕️ Clinical Trial & Toxicology Support
• Clinical trial protocol preparation, ethics submissions, and final report drafting.
• Toxicological study design and documentation following OECD and WHO norms.
🌏 Why Choose Us for the Lebanon Market
• Expert Team – Specialized in MOPH Lebanon, ICH, and WHO frameworks.
• End-to-End Regulatory Support – From dossier compilation to post-approval assistance.
• MENA Region Expertise – Experience with multiple Arab and regional regulatory systems.
• Efficient Turnaround – Fast, accurate documentation for timely approvals.
• Tailored Regulatory Strategies – Customized to product category and registration type.
📘 Regulatory & Dossier Documentation
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⚗️ Bioequivalence & Analytical Studies
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🧪 Technology Transfer & Safety
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