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

🇶🇦 Regulatory and Research Services for Qatar

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 Qatari (GCC) market.

Our services comply with MOPH Qatar, Pharmacy & Drug Control Department, GCC guidelines, GSO, and ICH/WHO standards.

📘 Regulatory Services for Qatar

🇶🇦 Regulatory & Product Registration Support – Qatar (GCC)

We support companies through all regulatory steps in Qatar, following:

✔ Ministry of Public Health (MOPH Qatar)
✔ Pharmacy & Drug Control Department (PDCD)
✔ GCC Central Drug Registration (GCC-DR)
✔ GSO Gulf Standards (Labeling, Cosmetics, Safety)
✔ Qatar Customs & Import Requirements
✔ ICH Q/S/E Guidelines

📘 Product Registration Services

• Qatar Dossier Preparation & Product Registration

– Preparation of CTD-format dossiers as required by MOPH
– National registration & GCC-DR submission support
– Food supplement & nutraceutical product registration
– Herbal & natural product registration
– Cosmetic product registration under Qatar MOPH regulations
– Ingredient compliance with GSO & Qatar-specific restricted/prohibited lists
– Safety, stability, and efficacy document preparation

• Qatar Label & Packaging Compliance

– Mandatory Arabic + English labeling
– Compliance with GSO labeling & safety standards
– Claims verification, allergen warnings, expiry & batch requirements
– IFU/leaflets & packaging artwork development

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

– Preparation of DMF/ASMF compliant with Qatar MOH & GCC
– CEP/US DMF bridging support
– GMP documentation (EU/US/WHO GMP recognized)
– API stability & quality documentation for Qatar import approval

⚗️ Bioequivalence (BE) Study Support – Qatar

– BE protocol design according to GCC & ICH guidelines
– Acceptance of foreign BE studies (EU/US/India) if accredited
– BE reporting & bridging documentation
– Biowaiver support for BCS Class I/III APIs

🔬 Analytical Method Validation (AMV) Services

– AMV as per ICH Q2(R2)
– Assay, impurities, dissolution & stability validation
– Preparation of AMV protocol + raw data + final validation report
– QC method transfer for Qatar submissions

🧾 Regulatory Consultancy & Compliance – Qatar

– Product classification under MOPH (medicine / supplement / cosmetic / herbal / veterinary)
– Support for Qatar MAH (Marketing Authorization Holder) requirements
– GMP/GDP compliance for Qatari importers & distributors
– Post-approval lifecycle management: variations, renewals, PSUR
– Monitoring updates from MOPH Qatar • PDCD • GSO • GCC

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

💊 Formulation Development

– Tablets, capsules, liquids, powders, injectables
– Stability studies suitable for GCC Zone IVb (Hot & Humid)
– Formulation optimization for Qatar’s climatic & regulatory needs

🧫 Analytical R&D Services

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

📑 Product Development Reports (PDRs)

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

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documents per ICH-GCP (E6)
– Support for clinical trial submission to Qatar MOPH
– Toxicology reporting per OECD guidelines
– Cosmetic safety files (PIF equivalent)

🌏 Why Choose Us for the Qatar Market

• Expertise in MOPH Qatar, PDCD, GCC-DR & GSO
• Complete regulatory, documentation & scientific support
• Experience across GCC, EU, US, ASEAN & ROW markets
• Fast & compliant CTD/DMF/AMV preparation
• Tailored regulatory pathways ensure faster product approval

📘 Regulatory & Dossier Documentation – Qatar/GCC

Hashtags – Qatar & GCC
#DossierQatar #DMFQatar #CTDQatar
#MOPHQatar #PharmaQatar #CosmeticsQatar
#FoodSupplementQatar #HerbalQatar #VeterinaryQatar
#PharmaComplianceGCC #StabilityStudiesGCC #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Qatar

#BEStudiesGCC #BioequivalenceQatar #AMV
#AssayValidation #DissolutionValidation

🧪 Technology Transfer & Safety – Qatar

#TechnologyTransferGCC #MethodTransfer #MSDS
#PharmaTechTransferQatar