Regulatory And Research Services for Saudi-Arabia
🇸🇦 Regulatory and Research Services for Saudi Arabia – 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 Saudi Arabia market.
Our services ensure full compliance with the Saudi Food & Drug Authority (SFDA), as well as WHO and ICH guidelines.
📘 Regulatory Services for Saudi Arabia
Regulatory & Product Registration Support – Saudi Arabia
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with SFDA, 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 SFDA regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Saudi Arabia.
• Support in preparing quality, safety, and stability documentation in line with SFDA and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in SFDA-approved CROs.
• Preparation of BE study protocols and reports according to WHO and SFDA requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods as per ICH Q2(R2) guidelines.
• Preparation of AMV documentation for regulatory submission and routine QC.
🧾 Regulatory Consultancy & Compliance
• Strategic regulatory guidance for entry into the Saudi Arabia market.
• Assistance with import/export licensing, SFDA inspections, renewals, and post-approval compliance.
• Continuous updates on SFDA regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Saudi Arabia
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with SFDA and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Saudi Arabia’s climatic conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per SFDA requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to SFDA.
• 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 SFDA submission.
🌏 Why Choose Us for the Saudi Arabia Market
• Experienced Regulatory Experts – Skilled in SFDA, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across GCC and MENA 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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