Regulatory And Research Services for Yemen
🇾🇪 Regulatory and Research Services for Yemen – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research services for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Yemen market.
Our services ensure full compliance with the Yemeni Ministry of Public Health and Population (MoPHP), as well as WHO and ICH guidelines.
📘 Regulatory Services for Yemen
Regulatory & Product Registration Support – Yemen
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with MoPHP Yemen, ensuring smooth market access and full regulatory compliance.
📘 Product Registration Services
• Preparation and submission of registration dossiers for prescription (Rx) and OTC products.
• Registration support for Herbal, Traditional, Nutraceutical, Veterinary, and Cosmetic products.
• Guidance on labeling, packaging, and product information leaflets according to MoPHP Yemen regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Yemen.
• Support in preparing quality, safety, and stability documentation in line with MoPHP Yemen and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in MoPHP-approved CROs.
• Preparation of BE study protocols and reports according to WHO and MoPHP Yemen requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods in compliance with ICH Q2(R2).
• Preparation of AMV documentation for regulatory submission and routine QC.
🧾 Regulatory Consultancy & Compliance
• Strategic regulatory guidance for entry into the Yemen market.
• Assistance with import/export licensing, MoPHP Yemen inspections, renewals, and post-approval compliance.
• Continuous updates on MoPHP Yemen regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Yemen
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with MoPHP Yemen and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Yemen’s climatic conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per MoPHP Yemen requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to MoPHP Yemen.
• Inclusion of formulation, manufacturing, QC, and stability data.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols, investigator brochures, and final reports.
• Toxicology studies according to OECD and WHO guidelines for MoPHP Yemen submission.
🌏 Why Choose Us for the Yemen Market
• Experienced Regulatory Experts – Skilled in MoPHP Yemen, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across Middle East markets.
• Efficient Documentation – Streamlined processes for faster regulatory approvals.
• Custom Strategies – Tailored per product type, regulatory pathway, and market requirements.
📘 Regulatory & Dossier Documentation
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⚗️ Bioequivalence & Analytical Studies
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🧪 Technology Transfer & Safety
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