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