Regulatory And Research Services for Regulatory-Services-Coverage-by-Congo-Market
🇨🇬 Regulatory and Research Services for the Republic of the Congo (Congo-Brazzaville)
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, provide complete regulatory and research services for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Republic of the Congo market.
Our services fully comply with DPML, ACRP, Ministry of Health, CEMAC regional guidelines, and WHO/ICH international standards.
📘 Regulatory Services for Congo-Brazzaville
🇨🇬 Regulatory & Product Registration Support – Republic of the Congo
We guide companies through all regulatory requirements under:
✔ DPML – Direction de la Pharmacie et du Médicament
✔ ACRP – Congo Pharmaceutical Regulatory Authority
✔ Ministry of Health & Population
✔ CEMAC Regional Pharmaceutical Guidelines
✔ WHO/ICH Q/S/E Standards
Congo typically accepts CTD-like, CEMAC, and WHO-format dossiers.
📘 Product Registration Services
• Congo Dossier Preparation & Product Registration
– Pharmaceutical product registration (Rx/OTC)
– Herbal & traditional medicine registration
– Food supplement & nutraceutical registration
– Cosmetic product registration with DPML/ACRP
– Veterinary medicine registration (Agriculture/Animal Health Department)
– Ingredient compliance with CEMAC restricted/prohibited lists
– End-to-end submission support until approval
• Congo Label & Packaging Compliance
– Mandatory French labeling
– Compliance with Congo MoH labeling rules (CEMAC-aligned)
– Verification of warnings, dosage, expiry, safety & claims
– Packaging artwork + IFU development
📗 Drug Master File (DMF) / API Documentation – Congo
– DMF in CTD/WHO/CEMAC format
– CEP/US DMF/EU ASMF bridging accepted
– GMP documentation (EU/US/WHO recognized)
– API impurity, stability & quality documentation for imports
– Support for API import permit & technical approval
⚗️ Bioequivalence (BE) Study Support – Congo
– BE study protocols as per WHO + ICH guidelines
– Acceptance of foreign BE studies (India, EU, US, ASEAN)
– Biowaiver justification (BCS Class I/III)
– Full BE report preparation for DPML/ACRP evaluations
🔬 Analytical Method Validation (AMV) Services
– AMV as per ICH Q2(R2)
– Validation of: Assay • Impurities • Dissolution • Stability
– AMV protocol + raw data + complete validation report
– QC method transfer for African import-release testing
🧾 Regulatory Consultancy & Compliance – Congo
– Classification: Drug / Supplement / Herbal / Cosmetic / Veterinary
– Local Authorized Representative (Importer) support
– GMP/GDP requirements for Congo-Brazzaville
– Renewal, variation & safety reporting support
– Continuous monitoring of DPML, ACRP & CEMAC regulatory updates
🧪 Research & Development (R&D) Services – Congo Market
💊 Formulation Development
– Tablets, capsules, syrups, injectables, powders
– Stability studies for Zone IVb (Hot & Humid) climates
– Tailored formulation optimization for Central African conditions
🧫 Analytical R&D Services
– Assay, dissolution, impurities testing
– QC method development & validation
– Real-time & accelerated stability studies
📑 Product Development Reports (PDRs)
– PDR in CTD/WHO/CEMAC format
– Includes formulation, QC, process & stability summaries
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical documentation per ICH-GCP (E6)
– Toxicology dossiers per OECD guidelines
– Cosmetic safety files for DPML/ACRP approval
– Herbal/traditional safety & justification dossiers
🌏 Why Choose Us for the Congo Market
• Expertise with DPML, ACRP, CEMAC & WHO regulatory systems
• Full support from dossier creation → submission → approval → renewal
• Strong African regulatory experience (Congo, Gabon, Cameroon, DRC, Rwanda)
• Faster approvals through complete & compliant documentation
• Affordable and efficient regulatory strategies
📘 Regulatory & Dossier Documentation – Congo/CEMAC
Hashtags – Congo Market
#DossierCongo #RegulatoryCongo #DPMECongo #ACRP
#PharmaCongo #CosmeticsCongo #SupplementsCongo
#HerbalCongo #VeterinaryCongo #CEMAC #WHOCTD
#StabilityStudiesAfrica #BMR #MFR
⚗️ Bioequivalence & Analytical Studies – Congo
#BEStudiesAfrica #BioequivalenceCongo #AMV
#DissolutionValidation #AssayValidation
🧪 Technology Transfer & Safety – Congo
#TechnologyTransferAfrica #MethodTransfer #MSDS
#PharmaTechTransferCongo