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