Regulatory And Research Services for Syria
🇸🇾 Regulatory and Research Services for Syria – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research services for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Syria market.
Our services ensure full compliance with the Syrian Ministry of Health (MOH), as well as WHO and ICH guidelines.
📘 Regulatory Services for Syria
Regulatory & Product Registration Support – Syria
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with MOH Syria, ensuring smooth market access and full regulatory compliance.
📘 Product Registration Services
• Preparation and submission of registration dossiers for prescription (Rx) and OTC products.
• Registration support for Herbal, Traditional, Nutraceutical, Veterinary, and Cosmetic products.
• Guidance on labeling, packaging, and product information leaflets according to MOH Syria regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Syria.
• Support in preparing quality, safety, and stability documentation in line with MOH Syria and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in MOH-approved CROs.
• Preparation of BE study protocols and reports according to WHO and MOH Syria requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods in compliance with ICH Q2(R2).
• Preparation of AMV documentation for regulatory submission and routine QC.
🧾 Regulatory Consultancy & Compliance
• Strategic regulatory guidance for entry into the Syria market.
• Assistance with import/export licensing, MOH Syria inspections, renewals, and post-approval compliance.
• Continuous updates on MOH Syria regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Syria
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with MOH Syria and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Syria’s climatic conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per MOH Syria requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to MOH Syria.
• Inclusion of formulation, manufacturing, QC, and stability data.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols, investigator brochures, and final reports.
• Toxicology studies according to OECD and WHO guidelines for MOH Syria submission.
🌏 Why Choose Us for the Syria Market
• Experienced Regulatory Experts – Skilled in MOH Syria, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across Middle East markets.
• Efficient Documentation – Streamlined processes for faster regulatory approvals.
• Custom Strategies – Tailored per product type, regulatory pathway, and market requirements.
📘 Regulatory & Dossier Documentation
#Dossier #DMF #DrugMasterFile #CTD #ACTD #RegulatorySubmission #RegulatoryDocumentation #PharmaDossier #M4 #M5 #PDR #PSUR #ClinicalTrialReport #CTReport #StabilityStudies #ToxicityReport #PharmaValidation #ProcessValidation #BMR #MFR #PharmaManufacturing #PharmaQuality #PharmaCompliance
#DossierSyria #DMFSyria #DrugMasterFileSyria #CTDSyria #ACTDSyria #RegulatorySubmissionSyria #RegulatoryDocumentationSyria #PharmaDossierSyria #M4Syria #M5Syria #PDRSyria #PSURSyria #ClinicalTrialReportSyria #CTReportSyria #StabilityStudiesSyria #ToxicityReportSyria #PharmaValidationSyria #ProcessValidationSyria #BMRSyria #MFRSyria #PharmaManufacturingSyria #PharmaQualitySyria #PharmaComplianceSyria
⚗️ Bioequivalence & Analytical Studies
#BEStudies #BioequivalenceStudy #PharmaBE #AnalyticalMethodValidation #AMV #PharmaAnalysis #MethodValidation #AssayValidation #DissolutionValidation #ReferenceStandardValidation #AMVAssay #AMVDissolution #AMVRS
#BEStudiesSyria #BioequivalenceStudySyria #PharmaBESyria #AnalyticalMethodValidationSyria #AMVSyria #PharmaAnalysisSyria #MethodValidationSyria #AssayValidationSyria #DissolutionValidationSyria #ReferenceStandardValidationSyria #AMVAssaySyria #AMVDissolutionSyria #AMVRSSyria
🧪 Technology Transfer & Safety
#TechnologyTransfer #PharmaTechTransfer #MSDS #MaterialSafetyDataSheet #ProductTransfer #AnalyticalTransfer #MethodTransfer
#TechnologyTransferSyria #PharmaTechTransferSyria #MSDSSyria #MaterialSafetyDataSheetSyria #ProductTransferSyria #AnalyticalTransferSyria #MethodTransferSyria
🌐 Top Pharma & Regulatory Hashtags – Syria
#PharmaSyria #PharmaIndustrySyria #DossierSyria #DMFSyria #CTDSyria #ACTDSyria #RegulatorySubmissionSyria #PharmaDossierSyria #PharmaComplianceSyria #PharmaQualitySyria #PharmaManufacturingSyria #PharmaValidationSyria #ProcessValidationSyria #BMRSyria #MFRSyria #StabilityStudiesSyria #PSURSyria #ClinicalTrialReportSyria #CTReportSyria #ToxicityReportSyria #BEStudiesSyria #BioequivalenceStudySyria #PharmaBESyria #AMVSyria #AnalyticalMethodValidationSyria #AssayValidationSyria #DissolutionValidationSyria #AMVAssaySyria #AMVDissolutionSyria #AMVRSSyria #TechnologyTransferSyria #PharmaTechTransferSyria #AnalyticalTransferSyria #MethodTransferSyria #MSDSSyria