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

🇧🇯 Regulatory and Research Services for Benin

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, offer complete regulatory and research services for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Benin (West Africa) market.

Our services comply with DPMED, ABSSA, ECOWAS/UEMOA regional rules, and global WHO/ICH guidelines.

📘 Regulatory Services for Benin

🇧🇯 Regulatory & Product Registration Support – Benin (West Africa)

We support companies through Benin’s regulatory pathways, ensuring alignment with:

✔ DPMED – Direction de la Pharmacie et du Médicament
✔ Ministry of Health (Benin)
✔ ABSSA – Food Safety Authority (supplements & foods)
✔ UEMOA/WAEMU Regional Pharmaceutical Guidelines
✔ ECOWAS Harmonized Medicines Regulations
✔ WHO/ICH Quality, Safety & Efficacy Guidelines

Benin typically accepts CTD-like, WHO-type, and regional ECOWAS dossier formats.

📘 Product Registration Services

• Benin Dossier Preparation & Product Registration

– Pharmaceutical product registration (Rx/OTC)
– Herbal, traditional & natural product registration
– Food supplement & nutraceutical registration with ABSSA
– Cosmetic product registration with DPMED / MoH
– Veterinary product registration under Agriculture/Animal Health Authority
– Ingredient safety checks (national & ECOWAS restricted lists)
– Complete regulatory submission & approval support

• Benin Label & Packaging Compliance

– Mandatory French labeling
– Compliance with Benin MoH + ABSSA labeling requirements
– Warnings, dosage, batch, expiry & storage statements
– Artwork, IFU & packaging development

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

– DMF dossier in CTD/WHO/ECOWAS format
– GMP documentation (EU/US/WHO GMP accepted)
– API stability, impurity & quality documentation
– CEP/US DMF bridging for Benin regulatory acceptance
– API import authorization support

⚗️ Bioequivalence (BE) Study Support – Benin

– BE studies following WHO + ICH
– International BE studies (India/EU/US) accepted with bridging
– Biowaiver support (BCS Class I/III)
– Full BE report & documentation for DPMED approval

🔬 Analytical Method Validation (AMV) Services

– AMV as per ICH Q2(R2)
– Validation of assay, impurity profiling, dissolution, stability
– AMV protocol + raw data + final report
– QC method transfer for West African testing labs

🧾 Regulatory Consultancy & Compliance – Benin

– Product classification (Drug / Supplement / Cosmetic / Herbal / Veterinary)
– Local Authorized Representative (Importer) guidance
– GMP/GDP compliance support for exporters/importers
– Post-approval maintenance: variations, renewals, safety updates
– Monitoring Benin MoH, UEMOA & ECOWAS regulatory developments

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

💊 Formulation Development

– Tablets, capsules, syrups, injectables, powders
– Stability studies suitable for hot & humid African climate (Zone IVb)
– Product adaptation for local climatic & regulatory requirements

🧫 Analytical R&D Services

– Assay, dissolution, impurities testing
– Stability studies (real-time & accelerated)
– QC method development & validation

📑 Product Development Reports (PDRs)

– PDR prepared in CTD/WHO/ECOWAS format
– Includes formulation, QC data & stability results

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documentation per ICH-GCP (E6)
– Toxicology dossier preparation (OECD-compliant)
– Cosmetic safety documentation per CEMAC/UEMOA practices
– Herbal product safety & literature-based justification

🌏 Why Choose Us for the Benin Market

• Expertise in DPMED, ABSSA, ECOWAS & UEMOA regulations
• Deep experience in Francophone Africa markets
• Fast, compliant dossier preparation for drugs, supplements & cosmetics
• End-to-end support from documentation to registration and post-approval
• Regulatory pathways tailored for Benin & West African regional markets

📘 Regulatory & Dossier Documentation – Benin/West Africa

Hashtags – Benin Market
#DossierBenin #RegulatoryBenin #DPMEDBenin
#PharmaBenin #CosmeticsBenin #SupplementsBenin
#HerbalProductsBenin #VeterinaryBenin
#ECOWASRegulation #UEMOA #DMF #CTD #StabilityStudies

⚗️ Bioequivalence & Analytical Studies – Benin

#BEStudiesAfrica #BioequivalenceBenin #AMV
#AssayValidation #DissolutionValidation

🧪 Technology Transfer & Safety – Benin

#TechnologyTransferAfrica #MethodTransfer #MSDS
#PharmaTechTransferBenin