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