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

🇷🇼 Regulatory and Research Services for Rwanda

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

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

Our services comply with RFDA, the Ministry of Health, EAC harmonized guidelines, RSB standards, and WHO/ICH international requirements.

📘 Regulatory Services for Rwanda

🇷🇼 Regulatory & Product Registration Support – Rwanda

We assist companies through all regulatory pathways under:

✔ RFDA – Rwanda Food and Drugs Authority
✔ MoH Rwanda
✔ EAC Medicines Regulatory Harmonization (EAC-MRH)
✔ Rwanda Standards Board (RSB)
✔ WHO/ICH Q/S/E Guidelines

Rwanda accepts CTD-format, WHO-format, and EAC harmonized dossiers for medicines.

📘 Product Registration Services

• Rwanda Dossier Preparation & Product Registration

– Pharmaceutical registration (Rx/OTC) with RFDA
– Herbal & traditional medicine registration
– Nutraceutical & food supplement registration
– Cosmetic product registration with RFDA
– Veterinary product registration under Ministry of Agriculture
– Ingredient compliance based on RSB + RFDA restricted lists
– Full end-to-end submission support for faster approvals

• Rwanda Label & Packaging Compliance

– Mandatory English, French, or Kinyarwanda labeling (English preferred)
– Compliance with RFDA & RSB labeling regulations
– Verification of dosage, warnings, storage, expiry & claims
– Packaging, artwork & IFU development

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

– Submission of DMF/ASMF in CTD/WHO/EAC format
– CEP/US DMF/EU ASMF bridging accepted
– GMP documentation (EU/US/WHO/PIC/S recognized)
– API impurity, stability & safety documentation
– Support for API import approval

⚗️ Bioequivalence (BE) Study Support – Rwanda

– BE study protocols in line with WHO + ICH standards
– Acceptance of foreign BE studies (India/EU/US/ASEAN)
– Biowaiver support (BCS Class I/III)
– Complete BE report preparation for RFDA submission

🔬 Analytical Method Validation (AMV) Services

– AMV according to ICH Q2(R2)
– Validation of assay, impurities, dissolution & stability methods
– AMV protocol + raw data + final validation report
– QC method transfer for Rwanda import-release labs

🧾 Regulatory Consultancy & Compliance – Rwanda

– Product classification (drug / supplement / herbal / cosmetic / veterinary)
– Local Authorized Representative (LAR) support
– GMP/GDP compliance assistance
– Variations, renewals, post-approval maintenance
– Monitoring regulatory updates from RFDA & EAC

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

💊 Formulation Development

– Tablets, capsules, syrups, powders, injectables
– Stability testing for hot and humid climates (Zone IVb)
– Product adaptation for Rwanda’s environmental conditions

🧫 Analytical R&D Services

– Method development, assay, dissolution & impurity testing
– Stability studies (accelerated + real-time)
– Analytical validation per WHO/EAC/ICH

📑 Product Development Reports (PDRs)

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

🧍‍⚕️ Clinical Trial & Toxicology Support

– Study protocols & reports per ICH-GCP (E6)
– Toxicology evaluations per OECD standards
– Cosmetic safety dossiers for RFDA compliance
– Safety assessments for herbal & traditional products

🌏 Why Choose Us for the Rwanda Market

• Deep expertise in RFDA & EAC-MRH regulatory systems
• Full service from classification → dossier → approval
• Strong African regulatory experience (Rwanda, Uganda, Kenya, Tanzania)
• Faster approvals with complete CTD/WHO documentation
• Global exposure: GCC, EU, US, Africa & ASEAN markets

📘 Regulatory & Dossier Documentation – Rwanda

Hashtags – Rwanda Market
#DossierRwanda #RegulatoryRwanda #RFDARwanda
#PharmaRwanda #CosmeticsRwanda #SupplementsRwanda
#HerbalRwanda #VeterinaryRwanda #EACMRH
#WHOCTD #StabilityStudiesAfrica #DMF #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Rwanda

#BEStudiesAfrica #BioequivalenceRwanda #AMV
#DissolutionValidation #AssayValidation

🧪 Technology Transfer & Safety – Rwanda

#TechnologyTransferAfrica #MethodTransfer #MSDS
#PharmaTechTransferRwanda