Regulatory And Research Services for Regulatory-Services-Coverage-by-Guinea-Market
🇬🇳 Regulatory and Research Services for Guinea
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, offer complete regulatory and research solutions for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Republic of Guinea market.
Our services follow the regulatory requirements of DNPL, ANSS, the Ministry of Health, and regional ECOWAS/UEMOA guidelines, as well as global WHO/ICH standards.
📘 Regulatory Services for Guinea
🇬🇳 Regulatory & Product Registration Support – Guinea (West Africa)
We guide companies through all Guinea regulatory pathways in compliance with:
✔ DNPL – Direction Nationale de la Pharmacie et du Laboratoire
✔ ANSS – National Agency for Health Security
✔ Guinea Ministry of Health
✔ ECOWAS Harmonized Medicines Regulations
✔ UEMOA Pharmaceutical Guidelines
✔ WHO/ICH Quality, Safety & Efficacy Standards
Guinea typically accepts CTD-like, ECOWAS, and WHO-format dossiers.
📘 Product Registration Services
• Guinea Dossier Preparation & Product Registration
– Pharmaceutical product registration (Rx/OTC)
– Herbal & traditional medicine registration (DNPL)
– Food supplement / nutraceutical registration (ANSS)
– Cosmetic product registration (ANSS / Ministry of Health)
– Veterinary medicine registration with Agriculture/Animal Health Authority
– Ingredient compliance checks (national & regional prohibitions)
– Complete dossier preparation, submission & follow-up
• Guinea Label & Packaging Compliance
– Mandatory French labeling
– Compliance with Guinea MoH & ANSS labeling rules
– Safety statements, dosage, warnings, expiry & storage requirements
– Packaging, artwork, IFU preparation as per Guinea standards
📗 Drug Master File (DMF) / API Documentation – Guinea
– DMF preparation in CTD/WHO/ECOWAS format
– CEP/US DMF/EU ASMF bridging acceptable
– GMP documentation (EU/US/WHO GMP recognized)
– API safety, impurity & stability documentation for Guinea import approval
– Support for API import permits & technical approval by DNPL
⚗️ Bioequivalence (BE) Study Support – Guinea
– BE protocols according to WHO + ICH guidance
– Acceptance of foreign BE studies (India/EU/US/ASEAN) when accredited
– Biowaiver support (BCS Class I/III APIs)
– Full BE report preparation compliant with ECOWAS expectations
🔬 Analytical Method Validation (AMV) Services
– AMV according to ICH Q2(R2)
– Validation for assay, impurities, dissolution & stability
– AMV protocol + raw data + complete validation report
– Analytical method transfer support for Guinea QC labs
🧾 Regulatory Consultancy & Compliance – Guinea
– Product classification: Drug / Supplement / Herbal / Cosmetic / Veterinary
– Local Authorized Representative (Importer) coordination
– GMP/GDP compliance for Guinea importers & distributors
– Renewal, variation & regulatory maintenance support
– Ongoing monitoring of DNPL, ANSS, ECOWAS & UEMOA regulatory updates
🧪 Research & Development (R&D) Services – Guinea Market
💊 Formulation Development
– Tablets, capsules, syrups, injectables, powders
– Stability studies for hot & humid tropical climate (Zone IVb)
– Formulation adjustment to Guinea environmental conditions
🧫 Analytical R&D Services
– Assay, dissolution, impurity profiling & stability testing
– QC method development & validation
– Real-time & accelerated stability programs
📑 Product Development Reports (PDRs)
– PDR in CTD/WHO/ECOWAS format
– Includes formulation development, analytical data & stability summary
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical trial documents per ICH-GCP
– Toxicology reports per OECD guidelines
– Cosmetic safety evaluation files
– Herbal/traditional medicine safety & scientific justification
🌏 Why Choose Us for the Guinea Market
• Expertise in DNPL, ANSS, ECOWAS & UEMOA regulations
• Strong experience across West Africa (Guinea, Senegal, Mali, Sierra Leone, Liberia)
• Complete support from dossier preparation → submission → approval
• WHO-format dossier expertise ensures fast approvals
• Cost-effective, efficient, and compliant regulatory execution
📘 Regulatory & Dossier Documentation – Guinea
Hashtags – Guinea Market
#DossierGuinea #RegulatoryGuinea #DNPLGuinea #ANSSGuinea
#PharmaGuinea #CosmeticsGuinea #SupplementsGuinea
#HerbalGuinea #VeterinaryGuinea
#ECOWASRegulation #WHOCTD #DMF #StabilityStudiesAfrica #BMR #MFR
⚗️ Bioequivalence & Analytical Studies – Guinea
#BEStudiesAfrica #BioequivalenceGuinea #AMV
#DissolutionValidation #AssayValidation
🧪 Technology Transfer & Safety – Guinea
#TechnologyTransferAfrica #MethodTransfer #MSDS
#PharmaTechTransferGuinea