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

🇦🇪 Regulatory and Research Services for the United Arab Emirates (UAE)

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 UAE (GCC) market.

Our services comply with MOHAP, DHA, DOH, Dubai Municipality, GCC guidelines, GSO standards, and ICH/WHO global regulatory frameworks.

📘 Regulatory Services for the UAE

🇦🇪 Regulatory & Product Registration Support – UAE

We provide end-to-end regulatory assistance with all UAE authorities:

✔ MOHAP – UAE Ministry of Health & Prevention (Drugs, Supplements, Medical Products)
✔ DHA – Dubai Health Authority (Dubai-specific approvals)
✔ DoH Abu Dhabi – Department of Health
✔ Dubai Municipality – Cosmetics & Personal Care Registration
✔ GCC-DR – Gulf Central Registration for Pharmaceuticals
✔ GSO Standards – Labeling, Safety, Ingredient Lists
✔ UAE Customs & Import Clearance Rules
✔ ICH Q/S/E Guidelines

📘 Product Registration Services

• UAE Dossier Preparation & Product Registration

– Pharmaceutical drug registration with MOHAP (CTD format)
– GCC-DR centralized registration support
– Food supplement / vitamin / nutraceutical registration with MOHAP
– Herbal / Traditional medicine registration
– Cosmetic product registration via Dubai Municipality Montaji System
– Ingredient review against GSO + ESMA restricted/prohibited lists
– Safety, stability, and quality documentation compliant with UAE requirements

• UAE Label & Packaging Compliance

– Mandatory Arabic + English labeling
– Compliance with GSO labeling standards
– QR code/serialisation (where applicable)
– Review of allergens, warnings, claims & instructions
– Artwork, packaging & IFU development per UAE regulations

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

– Preparation of DMF/ASMF for MOHAP & GCC submissions
– Bridging CEP/US DMF/EU ASMF to UAE format
– ICH Q8/Q9/Q10 quality documentation
– GMP compliance (EU/US/WHO GMP accepted)
– API safety, stability & impurity data for UAE import approval

⚗️ Bioequivalence (BE) Study Support – UAE

– BE study protocol design per GCC + ICH guidelines
– Coordination with GCC-approved CROs
– Acceptance of foreign BE studies (EU/US/India) if certified
– Biowaiver support (BCS Class I/III APIs)
– BE report compilation for UAE submission

🔬 Analytical Method Validation (AMV) Services

– AMV according to ICH Q2(R2)
– Assay, impurities, dissolution, stability validations
– AMV protocol, raw data & validation reports
– Analytical method transfer for UAE testing labs

🧾 Regulatory Consultancy & Compliance – UAE

– Product classification:
✔ Drug
✔ Supplement
✔ Cosmetic
✔ Herbal
✔ Veterinary
– UAE Authorized Representative (local agent) guidance
– GMP/GDP readiness for UAE importers
– Post-approval: variations, renewals, PSUR, pharmacovigilance
– Monitoring UAE & GCC regulatory changes

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

💊 Formulation Development

– Tablets, capsules, liquids, powders, injectables
– Stability studies under GCC Zone IVb (Hot & Humid)
– Product optimization for UAE climate & regulatory expectations

🧫 Analytical R&D Services

– Assay, dissolution, impurities, stability studies
– QC method development & validation
– Accelerated & real-time stability programs

📑 Product Development Reports (PDRs)

– Preparation of PDR in CTD format
– Includes formulation, QC methods, process & stability data

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial document preparation per ICH-GCP (E6)
– Support for clinical trials via MOHAP / DHA / DoH
– Toxicology evaluation per OECD guidelines
– Cosmetic safety files (PIF-equivalent) for Dubai Municipality

🌏 Why Choose Us for the UAE Market

• Expertise in MOHAP, DHA, DOH Abu Dhabi, Dubai Municipality & GCC-DR
• End-to-end regulatory, documentation & technical support
• Strong experience across GCC, EU, ASEAN, Africa & US markets
• Fast & compliant CTD/DMF/AMV preparation
• Tailored regulatory pathways ensure smooth UAE market entry

📘 Regulatory & Dossier Documentation – UAE/GCC

Hashtags – UAE & GCC
#DossierUAE #DMFUAE #CTDUAE
#MOHAPUAE #DHADubai #DoHAbuDhabi
#MontajiDubai #CosmeticsUAE #SupplementsUAE
#PharmaComplianceGCC #StabilityStudiesGCC #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – UAE

#BEStudiesGCC #BioequivalenceUAE #AMV
#DissolutionValidation #AssayValidation

🧪 Technology Transfer & Safety – UAE

#TechnologyTransferUAE #MethodTransfer #MSDS
#PharmaTechTransferUAE