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

🇴🇲 Regulatory and Research Services for Oman

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 Omani (GCC) market.

Our services comply with DGPA&DC, MOH Oman, GCC guidelines, GSO standards, and international ICH/WHO norms.

📘 Regulatory Services for Oman

🇴🇲 Regulatory & Product Registration Support – Oman (GCC)

We support companies through all stages of Oman’s national and GCC regulatory pathway based on:

✔ Directorate General of Pharmaceutical Affairs & Drug Control (DGPA&DC)
✔ Ministry of Health (MOH Oman)
✔ GCC Drug Registration — GCC-DR
✔ GSO Labeling & Safety Standards
✔ Oman Customs & Import Permits
✔ ICH Q/S/E Guidelines

📘 Product Registration Services

• Oman Dossier Preparation & Product Registration

– Preparation of CTD-compliant dossiers for pharmaceuticals (Rx/OTC)
– National registration with DGPA&DC
– GCC-DR support for centralized GCC submissions
– Vitamins, nutraceuticals & food supplements registration
– Herbal and natural product registration
– Cosmetic product registration under Oman’s MOH framework
– Ingredient reviews as per GSO restricted/prohibited lists

• Oman Label & Packaging Compliance

– Mandatory Arabic + English labeling
– GSO-compliant label formatting
– Review of therapeutic claims, warnings, batch details, expiry
– IFU/leaflet & packaging artwork as per Omani rules

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

– Preparation of DMF/ASMF for Oman & GCC
– ICH-compliant QOS, Module 3 & technical documentation
– CEP/US DMF bridging support
– GMP documentation as required by DGPA&DC
– API stability & safety documentation for import approval

⚗️ Bioequivalence (BE) Study Support – Oman

– BE protocol design per GCC + ICH guidelines
– Acceptance of foreign BE studies (EU/US/India) with accreditation
– Full BE report preparation for Oman submissions
– Biowaiver (BCS Class I/III) justification

🔬 Analytical Method Validation (AMV) Services

– AMV according to ICH Q2(R2)
– Assay, impurity, dissolution, stability & method transfer validation
– AMV protocols, raw data & validation reports
– QC method support for Omani import testing

🧾 Regulatory Consultancy & Compliance – Oman

– Product classification: medicine / supplement / cosmetic / herbal / veterinary
– Local importer/authorized representative support
– GMP/GDP compliance guidance for Omani distributors
– Post-approval: variations, renewals, safety reports, PMF
– Monitoring Oman MOH, GCC & GSO regulatory updates

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

💊 Formulation Development

– Tablets, capsules, liquids, syrups, powders, injectables
– Stability testing for GCC climatic Zone IVb (Hot & Humid)
– Formulation optimization for Omani climate & regulations

🧫 Analytical R&D Services

– Assay, dissolution, impurity profiling
– QC method development & validation
– Real-time & accelerated stability studies

📑 Product Development Reports (PDRs)

– Preparation of PDR in CTD format
– Includes formulation, QC testing & stability summaries

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documentation per ICH-GCP (E6)
– Support for Oman MOH clinical trial submissions
– Toxicology evaluation per OECD guidelines
– Cosmetic safety documentation (Product Information File)

🌏 Why Choose Us for the Oman Market

• Extensive expertise with DGPA&DC, MOH Oman, GCC-DR & GSO
• End-to-end regulatory, scientific & documentation support
• Strong experience across GCC, EU, US, ASEAN & ROW markets
• Fast, compliant CTD/DMF/AMV preparation
• Accurate product classification ensures quick approvals

📘 Regulatory & Dossier Documentation – Oman/GCC

Hashtags – Oman & GCC
#DossierOman #DMFOman #CTDOman
#MOHOman #PharmaOman #CosmeticsOman
#FoodSupplementOman #HerbalOman #VeterinaryOman
#PharmaComplianceGCC #StabilityStudiesGCC #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Oman

#BEStudiesGCC #BioequivalenceOman #AMV
#AssayValidation #DissolutionValidation

🧪 Technology Transfer & Safety – Oman

#TechnologyTransferGCC #MethodTransfer
#MSDS #PharmaTechTransferOman