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

🇰🇲 Regulatory and Research Services for Comoros

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

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

Our services comply with DNPS, OCOPHAR, Comoros Ministry of Health regulations, and international WHO/ICH standards.
Comoros generally accepts CTD-like, WHO-format dossiers for drugs, supplements, and cosmetics.

📘 Regulatory Services for Comoros

🇰🇲 Regulatory & Product Registration Support – Comoros

We assist companies across all regulatory stages in line with:

✔ DNPS – National Directorate of Pharmacy & Health
✔ OCOPHAR – National Office of Pharmacy (import, licensing & distribution control)
✔ Ministry of Health (Comoros)
✔ WHO guidelines (CTD-lite accepted)
✔ African pharmaceutical regulatory harmonization trends

📘 Product Registration Services

• Comoros Dossier Preparation & Product Registration

– Pharmaceutical product registration (Rx/OTC) in CTD/WHO format
– Herbal & traditional medicine registration
– Nutraceutical & food supplement registration
– Cosmetic product registration with DNPS/Health Ministry
– Veterinary product registration (Agriculture/Animal Health Department)
– Ingredient compliance per Comoros & WHO restricted/prohibited lists
– Support for import license, documentation & local partner coordination

• Comoros Label & Packaging Compliance

– Mandatory French labeling
– Label review as per Comoros MoH rules
– Verification of warnings, expiry, dosage, storage, and claims
– Artwork, IFU & packaging creation

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

– DMF preparation in CTD/WHO format
– CEP/US DMF/EU DMF bridging where acceptable
– GMP documentation (EU/US/WHO GMP recognized)
– API impurity, stability & safety documentation for imports
– API approval support for OCOPHAR-controlled supply chain

⚗️ Bioequivalence (BE) Study Support – Comoros

– BE protocols per WHO + ICH
– Use of international BE data (India/EU/US/ASEAN) accepted with justification
– Biowaiver support (BCS Class I/III)
– BE report preparation for Comoros submission

🔬 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 import-release testing

🧾 Regulatory Consultancy & Compliance – Comoros

– Product classification: Drug / Supplement / Cosmetic / Herbal / Veterinary
– Local importer/representative guidance (OCOPHAR requirements)
– GMP/GDP compliance support
– Import permit management
– Post-approval services: variations, renewals & safety updates
– Monitoring regulatory updates in Comoros + Indian Ocean region

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

💊 Formulation Development

– Tablets, capsules, syrups, powders, injectables
– Stability testing for hot and humid tropical climate (Zone IVb)
– Formulation tuning for Comoros & island-market needs

🧫 Analytical R&D Services

– Assay, impurity profiling, dissolution
– Method development & validation
– Stability studies (accelerated + real-time)

📑 Product Development Reports (PDRs)

– PDR in CTD/WHO format
– Includes formulation, QC testing & stability summary

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documents per ICH-GCP
– Toxicology dossiers per OECD guidelines
– Cosmetic safety evaluation documentation
– Traditional medicine safety assessments

🌏 Why Choose Us for the Comoros Market

• Experts in DNPS + OCOPHAR regulatory requirements
• Full registration support for pharmaceuticals, cosmetics & supplements
• WHO-based dossier expertise ideal for Comoros approval
• Strong experience with Africa, GCC, ASEAN, EU & US markets
• Faster registration timelines through accurate documentation & classification

📘 Regulatory & Dossier Documentation – Comoros

Hashtags – Comoros Market
#DossierComoros #RegulatoryComoros #DNPS #OCOPHAR
#PharmaComoros #CosmeticsComoros #SupplementsComoros
#HerbalProductsComoros #VeterinaryComoros
#AfricaPharma #WHOCTD #StabilityStudies #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Comoros

#BEStudiesAfrica #BioequivalenceComoros #AMV
#AssayValidation #DissolutionValidation

🧪 Technology Transfer & Safety – Comoros

#TechnologyTransferAfrica #MethodTransfer #MSDS
#PharmaTechTransferComoros