Regulatory And Research Services for Mauritania

πŸ‡²πŸ‡· Regulatory and Research Services for Mauritania – 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 Mauritania market.
Our services ensure full compliance with the Direction de la Pharmacie et du MΓ©dicament (DPM Mauritania), as well as WHO and ICH guidelines.

πŸ“˜ Regulatory Services for Mauritania

Regulatory & Product Registration Support – Mauritania

We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with DPM Mauritania, ensuring smooth market access and full regulatory compliance.

πŸ“˜ Product Registration Services

β€’ Preparation and submission of registration dossiers for prescription (Rx) and OTC products.
β€’ Registration support for Herbal, Traditional, Nutraceutical, Veterinary, and Cosmetic products.
β€’ Guidance on labeling, packaging, and product information leaflets according to DPM Mauritania regulations.

πŸ“— Drug Master File (DMF) Services

β€’ Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Mauritania.
β€’ Support in preparing quality, safety, and stability documentation in line with DPM Mauritania and ICH standards.

βš—οΈ Bioequivalence (BE) Study Support

β€’ Design and coordination of BE studies in DPM-approved CROs.
β€’ Preparation of BE study protocols and reports according to WHO and DPM Mauritania requirements.

πŸ”¬ Analytical Method Validation (AMV) Services

β€’ Validation of analytical methods in compliance with ICH Q2(R2).
β€’ Preparation of AMV documentation for regulatory submission and routine QC.

🧾 Regulatory Consultancy & Compliance

β€’ Strategic regulatory guidance for entry into the Mauritania market.
β€’ Assistance with import/export licensing, DPM Mauritania inspections, renewals, and post-approval compliance.
β€’ Continuous updates on DPM Mauritania regulatory changes to ensure product compliance.

πŸ§ͺ Research & Development (R&D) Services – Mauritania

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

πŸ’Š Formulation Development

β€’ Development and optimization of tablets, capsules, syrups, powders, and injectables.
β€’ Stability studies designed for Mauritania’s climatic conditions.

🧫 Analytical R&D Services

β€’ Assay, dissolution, impurity profiling, and stability testing.
β€’ Analytical method development and transfer to partner laboratories per DPM Mauritania requirements.

πŸ“‘ Product Development Reports (PDRs)

β€’ Preparation of comprehensive PDRs for submission to DPM Mauritania.
β€’ Inclusion of formulation, manufacturing, QC, and stability data.

πŸ§β€βš•οΈ Clinical Trial & Toxicology Support

β€’ Preparation of clinical trial protocols, investigator brochures, and final reports.
β€’ Toxicology studies according to OECD and WHO guidelines for DPM Mauritania submission.

🌏 Why Choose Us for the Mauritania Market

β€’ Experienced Regulatory Experts – Skilled in DPM Mauritania, WHO, and ICH regulatory frameworks.
β€’ End-to-End Support – From dossier preparation to post-approval compliance.
β€’ Regional Expertise – Proven success across West Africa.
β€’ Efficient Documentation – Streamlined processes for faster regulatory approvals.
β€’ Custom Strategies – Tailored per product type, regulatory pathway, and market requirements.

πŸ“˜ Regulatory & Dossier Documentation

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βš—οΈ Bioequivalence & Analytical Studies

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πŸ§ͺ Technology Transfer & Safety

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🌐 Top Pharma & Regulatory Hashtags – Mauritania

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