Regulatory And Research Services for Regulatory-Services-Coverage-by-Burundi-Market

🇧🇮 Regulatory and Research Services for Burundi

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, provide comprehensive regulatory and research services for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Burundi market.

Our services comply with DPML/ABREMA, Ministry of Health, EAC harmonized guidelines, and WHO/ICH standards.

📘 Regulatory Services for Burundi

🇧🇮 Regulatory & Product Registration Support – Burundi (EAC Region)

We support companies across all stages of regulatory approval, following:

✔ DPML – Direction de la Pharmacie et du Médicament
✔ ABREMA – Burundi Food & Drug Regulatory Authority
✔ Ministry of Health (Burundi)
✔ EAC Medicines Regulatory Harmonization (MRH)
✔ WHO/ICH Q/S/E Guidelines

Burundi generally accepts CTD-like, WHO-type, and EAC harmonized dossier formats.

📘 Product Registration Services

• Burundi Dossier Preparation & Product Registration

– Pharmaceutical product registration (Rx/OTC) in CTD/WHO format
– Herbal & traditional medicine registration
– Food supplement & nutraceutical registration
– Cosmetic product registration (DPML/ABREMA)
– Veterinary product registration with Ministry of Agriculture
– Ingredient compliance with Burundi & EAC restricted lists
– Full submission preparation + follow-up until approval

• Burundi Label & Packaging Compliance

– Mandatory French and/or Kirundi (local language) labeling
– Compliance with MoH/ABREMA labeling rules
– Verification of warnings, dosage instructions, batch & expiry info
– Preparing artwork, IFU & packaging for Burundi standards

📗 Drug Master File (DMF) / API Documentation – Burundi

– Preparation of DMF/ASMF in WHO/EAC/CTD format
– GMP documentation (EU/US/WHO GMP accepted)
– Stability & impurity data for Burundi import approvals
– API bridging from US DMF/CEP where acceptable
– Support for API suppliers entering Burundi/regional markets

⚗️ Bioequivalence (BE) Study Support – Burundi

– BE protocol preparation per WHO + ICH guidelines
– Acceptance of foreign BE studies (India/EU/US/ASEAN)
– Biowaiver support (BCS Class I/III)
– BE report preparation in line with EAC/DPML requirements

🔬 Analytical Method Validation (AMV) Services

– AMV according to ICH Q2(R2)
– Assay, impurities, dissolution, stability validation
– AMV protocol + raw data + reports
– QC method transfer support for Burundi import-release labs

🧾 Regulatory Consultancy & Compliance – Burundi

– Product classification (Drug / Supplement / Cosmetic / Herbal / Veterinary)
– Local Authorized Representative/importer support
– GMP/GDP compliance advice
– Post-approval maintenance: renewals, variations & safety updates
– Monitoring changes in DPML → ABREMA transition regulations

🧪 Research & Development (R&D) Services – Burundi Market

💊 Formulation Development

– Tablets, capsules, syrups, injectables, powders
– Stability testing for Zone IVb (Hot & Humid African climate)
– Formulation optimization for local market conditions

🧫 Analytical R&D Services

– Assay, dissolution, impurities analysis
– Method development & validation
– Stability testing: accelerated & real-time

📑 Product Development Reports (PDRs)

– PDR prepared in WHO/CTD/EAC format
– Includes formulation development, QC methods & stability studies

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical documentation per ICH-GCP (E6)
– Toxicology studies per OECD guidelines
– Cosmetic safety files for ABREMA registration
– Traditional medicine safety & literature-based justification

🌏 Why Choose Us for the Burundi Market

• Expertise with DPML, ABREMA, EAC MRH regulatory systems
• Deep understanding of East African pharmaceutical requirements
• End-to-end support: dossier → registration → post-approval
• Global experience: Africa, GCC, EU, US, ASEAN & ROW
• Faster approvals through correct classification & complete documentation

📘 Regulatory & Dossier Documentation – Burundi/EAC

Hashtags – Burundi Market
#DossierBurundi #RegulatoryBurundi #DPMLBurundi #ABREMA
#PharmaBurundi #CosmeticsBurundi #SupplementsBurundi
#HerbalProductsBurundi #VeterinaryBurundi
#EACMRH #WHOCTD #DMF #StabilityStudies

⚗️ Bioequivalence & Analytical Studies – Burundi

#BEStudiesAfrica #BioequivalenceBurundi #AMV
#AssayValidation #DissolutionValidation

🧪 Technology Transfer & Safety – Burundi

#TechnologyTransferAfrica #MethodTransfer #MSDS
#PharmaTechTransferBurundi