Regulatory And Research Services for Egypt

🇪🇬 Regulatory and Research Services for Egypt – 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 Egypt market.
Our services ensure full compliance with the Egyptian Drug Authority (EDA), as well as WHO and ICH guidelines.

📘 Regulatory Services for Egypt

Regulatory & Product Registration Support – Egypt

We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with EDA Egypt, 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 EDA Egypt regulations.

📗 Drug Master File (DMF) Services

• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Egypt.
• Support in preparing quality, safety, and stability documentation in line with EDA Egypt and ICH standards.

⚗️ Bioequivalence (BE) Study Support

• Design and coordination of BE studies in EDA-approved CROs.
• Preparation of BE study protocols and reports according to WHO and EDA Egypt 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 Egypt market.
• Assistance with import/export licensing, EDA Egypt inspections, renewals, and post-approval compliance.
• Continuous updates on EDA Egypt regulatory changes to ensure product compliance.

🧪 Research & Development (R&D) Services – Egypt

Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with EDA Egypt and international standards.

💊 Formulation Development

• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Egypt’s climatic conditions.

🧫 Analytical R&D Services

• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per EDA Egypt requirements.

📑 Product Development Reports (PDRs)

• Preparation of comprehensive PDRs for submission to EDA Egypt.
• 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 EDA Egypt submission.

🌏 Why Choose Us for the Egypt Market

• Experienced Regulatory Experts – Skilled in EDA Egypt, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across North Africa 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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🌐 Top Pharma & Regulatory Hashtags – Egypt

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