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

🇸🇨 Regulatory and Research Services for Seychelles

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 Seychelles market.

Our services follow the requirements of SMCA, the Ministry of Health, Public Health Authority, SBS standards, and international WHO/ICH regulatory norms.

📘 Regulatory Services for Seychelles

🇸🇨 Regulatory & Product Registration Support – Seychelles

We guide companies through all Seychelles regulatory pathways in compliance with:

✔ SMCA – Seychelles Medicine Control Authority
✔ Ministry of Health, Seychelles
✔ Public Health Authority (PHA) — food supplements, herbal products
✔ Seychelles Bureau of Standards (SBS)
✔ WHO/ICH Q/S/E Guidelines

Seychelles accepts CTD-like and WHO-format dossiers for pharmaceuticals.

📘 Product Registration Services

• Seychelles Dossier Preparation & Product Registration

– Pharmaceutical product registration (Rx/OTC) with SMCA
– Food supplement & nutraceutical registration with PHA
– Herbal & traditional product registration
– Cosmetic product notification/registration with PHA
– Veterinary product registration (Agriculture & Veterinary Services)
– Ingredient compliance with Seychelles and WHO restricted/prohibited lists
– Submission and approval follow-up until final clearance

• Seychelles Label & Packaging Compliance

– Mandatory English labeling (French/Creole optional)
– Compliance with SMCA + PHA + SBS requirements
– Verification of warnings, dosage, expiry, batch & safety info
– Packaging, artwork & IFU development

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

– Preparation of DMF/ASMF in CTD/WHO format
– Bridging US DMF / EU ASMF / CEP where acceptable
– GMP documentation (EU/US/WHO/PIC/S recognized)
– API stability, impurity & quality documentation
– Support for API import approval

⚗️ Bioequivalence (BE) Study Support – Seychelles

– BE protocols based on WHO + ICH guidelines
– Acceptance of foreign BE studies (India/EU/US/ASEAN)
– Biowaiver support (BCS Class I/III)
– Full BE dossier preparation for SMCA review

🔬 Analytical Method Validation (AMV) Services

– AMV as per ICH Q2(R2)
– Validation of assay, impurities, dissolution & stability
– Preparation of AMV protocol + raw data + final report
– Method transfer support for Seychelles testing labs

🧾 Regulatory Consultancy & Compliance – Seychelles

– Product classification (drug / supplement / herbal / cosmetic / veterinary)
– Local Authorized Representative support
– GMP/GDP readiness support for importers & distributors
– Renewal, variation & regulatory maintenance
– Monitoring regulatory updates from SMCA, PHA, SBS & MoH

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

💊 Formulation Development

– Tablets, capsules, syrups, powders, injectables
– Stability testing for tropical humid Island climate (Zone IVb)
– Optimization for Seychelles market conditions

🧫 Analytical R&D Services

– Assay, dissolution, impurities, stability studies
– QC method development & validation
– Real-time & accelerated stability testing

📑 Product Development Reports (PDRs)

– PDR in CTD/WHO format
– Includes formulation, process, QC methods & stability data

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documents per ICH-GCP
– Toxicology evaluation as per OECD
– Cosmetic safety documentation (PIF-style)
– Herbal safety & justification & literature review

🌏 Why Choose Us for the Seychelles Market

• Expertise in SMCA, PHA & SBS regulatory systems
• Specialized in island-country regulatory pathways
• Experience with Africa, GCC, EU, ASEAN & Indian Ocean markets
• Fast, compliant CTD/DMF preparation
• Tailored support ensures smooth product approval

📘 Regulatory & Dossier Documentation – Seychelles

Hashtags – Seychelles Market
#DossierSeychelles #RegulatorySeychelles #SMCASeychelles
#PharmaSeychelles #CosmeticsSeychelles #SupplementsSeychelles
#HerbalSeychelles #VeterinarySeychelles #WHOCTD
#StabilityStudiesAfrica #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Seychelles

#BEStudiesAfrica #BioequivalenceSeychelles #AMV
#DissolutionValidation #AssayValidation

🧪 Technology Transfer & Safety – Seychelles

#TechnologyTransferAfrica #MethodTransfer #MSDS
#PharmaTechTransferSeychelles