Regulatory And Research Services for Regulatory-Services-Coverage-by-United Arab Emirates-Market
🇦🇪 Regulatory and Research Services for the United Arab Emirates
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, provide comprehensive regulatory and research solutions for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, veterinary, and medical product companies seeking entry into the UAE market.
Our services align with MOHAP, Dubai Municipality, DoH Abu Dhabi, DHA, GCC guidelines, and ICH/WHO standards.
📘 Regulatory Services for the UAE
🇦🇪 Regulatory & Product Registration Support – UAE
We offer complete support for registration with:
✔ MOHAP – Ministry of Health & Prevention (Pharmaceuticals, Supplements, Veterinary)
✔ DHA – Dubai Health Authority (Healthcare Products)
✔ DoH – Department of Health Abu Dhabi
✔ Dubai Municipality (Cosmetics, Personal Care)
✔ ESMA/MOEI (Standards & Metrology for specific product categories)
📘 Product Registration Services
• UAE Dossier Preparation & Registration
– MOHAP dossier preparation for pharmaceuticals (Rx/OTC)
– Food supplement registration (MOHAP category – nutraceuticals)
– Cosmetic product registration through Montaji (Dubai Municipality) & MOHAP
– Veterinary product registration under UAE Veterinary Services
– Herbal & Ayurveda product registration as per UAE guidelines
– Ingredient & claim compliance with UAE-specific regulations:
✔ UAE GSO standards
✔ GCC Cosmetic Regulation
✔ UAE Novel Food Framework
✔ UAE Health Claims Regulation
• UAE Label & Packaging Compliance
– Mandatory labeling in Arabic + English
– Compliance with UAE food label rules:
✔ Shelf-life labeling
✔ Country of origin
✔ Nutrition facts format
✔ Allergen declarations
– Cosmetic labeling as per Montaji/Dubai Municipality
– Artwork & IFU development as per UAE guidelines
📗 Drug Master File (DMF) / API Registration Services
– DMF preparation for MOHAP submission (CTD format acceptable)
– Adapting EU/US DMFs into UAE structure
– API documentation for manufacturers and importers
– ICH Q8/Q9/Q10-compliant quality section preparation
– Support for MOHAP approvals for APIs used in UAE-registered pharmaceuticals
⚗️ Bioequivalence (BE) Study Support – UAE
– BE study design following GCC + WHO + ICH guidelines
– Coordination with MOHAP-approved CROs
– Development of BE protocols and complete BE reports
– Biowaiver assistance (BCS-based), in line with GCC-DR guidelines
🔬 Analytical Method Validation (AMV) Services
– Validation as per ICH Q2(R2)
– Development of analytical methods for assay, impurities, dissolution, RS
– AMV protocol and validation report generation
– QC laboratory support for manufacturers exporting to UAE
🧾 Regulatory Consultancy & Compliance – UAE
– Classification guidance: pharma, supplement, cosmetic, herbal
– UAE Free Zone support: DHCC, JAFZA, Dubai Industrial City, RAKEZ
– Importer/Distributor licensing compliance
– GMP/GDP documentation for product importation
– Handling variations, renewals, post-approval submissions
– Regular updates on MOHAP/DHA/DoH regulatory changes
🧪 Research & Development (R&D) Services – UAE Market
💊 Formulation Development
– Tablets, capsules, liquids, syrups, powders, injectables
– Stability studies for Middle-East climate Zone IVb (Hot & Humid)
– Development based on UAE patient/market requirements
🧫 Analytical R&D Services
– Assay, dissolution, impurity profiling
– QC method development & validation
– Real-time & accelerated stability studies for UAE filing
📑 Product Development Reports (PDRs)
– PDRs in CTD format suited for MOHAP submission
– Process development, analytical testing, & stability summaries included
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical trial protocol design & reporting as per ICH-GCP (E6)
– Support for MOHAP-controlled clinical trial approvals
– Toxicology reporting per OECD
– Cosmetic safety documentation for UAE:
✔ CPSR (Cosmetic Product Safety Report)
✔ PIF compilation (Product Information File)
🌏 Why Choose Us for the UAE Market
• Strong expertise in MOHAP, Dubai Municipality, DHA, DoH requirements
• End-to-end product registration and regulatory support
• Extensive global experience across GCC, EU, US, ASEAN & ROW markets
• Fast and accurate CTD/DMF dossier preparation
• Customized regulatory strategies for UAE-specific product categories
📘 Regulatory & Dossier Documentation – UAE
Hashtags – UAE Market
#DossierUAE #DMFUAE #CTDUAE #MOHAP #Montaji #DubaiMunicipality
#PharmaUAE #RegulatoryUAE #PharmaComplianceUAE
#FoodSupplementUAE #CosmeticsUAE #HerbalUAE
#VeterinaryUAE #StabilityStudiesUAE #ClinicalTrialUAE
#ProcessValidationUAE #BMR #MFR
⚗️ Bioequivalence & Analytical Studies – UAE
#BEStudiesUAE #BioequivalenceUAE #AnalyticalMethodValidationUAE
#AMVUAE #DissolutionValidation #AssayValidation
🧪 Technology Transfer & Safety – UAE
#TechnologyTransferUAE #PharmaTechTransferUAE
#AnalyticalTransferUAE #MethodTransferUAE #MSDSUAE
🌐 Top Pharma & Regulatory Hashtags – UAE
#PharmaUAE #UAEHealth #MOHAPUAE #DubaiMunicipality
#GCCRegulatory #UAECompliance #CTDUAE #DMFUAE