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