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

🇲🇻 Regulatory and Research Services for Maldives

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

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

Our services comply with MFDA, MoH Maldives, import regulations, and international WHO/ICH standards.

📘 Regulatory Services for Maldives

🇲🇻 Regulatory & Product Registration Support – Maldives

We support companies through all regulatory procedures for entering the Maldives market under:

✔ MFDA – Maldives Food and Drug Authority
✔ Ministry of Health (Maldives)
✔ Maldives Cosmetics Regulation
✔ Maldives Import/Customs Regulatory Requirements
✔ WHO/ICH Guidelines

Maldives accepts CTD-like dossiers and simplified formats for supplements and cosmetics.

📘 Product Registration Services

• Maldives Dossier Preparation & Product Registration

– Pharmaceutical product registration (CTD-based local format)
– Food supplement / nutraceutical registration with MFDA
– Herbal & traditional medicine registration
– Cosmetics registration (MFDA Product Approval System)
– Veterinary product registration (Ministry of Agriculture/Animal Health)
– Ingredient compliance checks (MFDA restricted/prohibited lists)

• Maldives Label & Packaging Compliance

– Mandatory English labeling (Dhivehi optional)
– Compliance with MFDA labeling requirements
– Review of claims, warnings & indications
– Artwork, IFU & packaging preparation

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

– Preparation of CTD/WHO-style DMFs accepted by MFDA
– Bridging of US DMF / CEP / EU ASMF to Maldives format
– GMP documentation review (EU/US/WHO GMP accepted)
– API quality & stability documentation for import approvals

⚗️ Bioequivalence (BE) Study Support – Maldives

– BE study protocols as per WHO + ICH guidelines
– Acceptance of foreign BE reports (EU/US/India/ASEAN)
– Biowaiver support (BCS Class I/III)
– Preparation of BE documentation for MFDA registration

🔬 Analytical Method Validation (AMV) Services

– AMV in accordance with ICH Q2(R2)
– Development & validation of assay, impurities, dissolution & stability methods
– AMV protocol + final validation report
– QC method transfer for Maldives importers

🧾 Regulatory Consultancy & Compliance – Maldives

– Product classification: medicine / supplement / cosmetic / herbal / veterinary
– Local importer & Authorized Agent support
– GMP/GDP compliance guidance for Maldives distributors
– Post-approval: variations, re-registration, safety documentation
– Monitoring MFDA & MoH regulatory updates

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

💊 Formulation Development

– Tablets, capsules, syrups, liquids, powders, injectables
– Stability testing for hot and humid tropical climates
– Formulation optimization for Maldives regulatory expectations

🧫 Analytical R&D Services

– Method development & validation
– Impurity profiling, stability studies, assay, dissolution
– WHO-compliant stability studies (real-time & accelerated)

📑 Product Development Reports (PDRs)

– Preparation of PDR in CTD/WHO format
– Includes formulation development, QC methods & stability data

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documentation per ICH-GCP (E6)
– Toxicology dossiers following OECD guidelines
– Cosmetic safety documentation (PIF-style dossier)

🌏 Why Choose Us for the Maldives Market

• Expertise in MFDA & Maldives MOH regulatory systems
• End-to-end registration, documentation & compliance support
• Strong global experience across SAARC, GCC, EU, US & ASEAN
• Fast, compliant dossier preparation for pharmaceuticals, supplements & cosmetics
• Cost-effective and accurate regulatory pathways for Maldives

📘 Regulatory & Dossier Documentation – Maldives

Hashtags – Maldives Market
#DossierMaldives #RegulatoryMaldives #MFDAMaldives
#PharmaMaldives #CosmeticsMaldives #SupplementsMaldives
#HerbalProductsMaldives #VeterinaryMaldives
#PharmaComplianceAsia #CTD #DMF #StabilityStudies #BMR #MFR

⚗️ Bioequivalence & Analytical Services – Maldives

#BEStudiesMaldives #BioequivalenceAsia #AMV
#DissolutionValidation #AssayValidation

🧪 Technology Transfer & Safety – Maldives

#TechnologyTransferAsia #MethodTransfer #MSDS
#PharmaTechTransfer