Regulatory And Research Services for Mongolia
🇲🇳 Regulatory and Research Services for Mongolia – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing complete regulatory and research solutions for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Mongolia market.
Our services ensure full compliance with the Mongolian Medicines Agency (MMA) under the Ministry of Health of Mongolia, as well as ICH and WHO guidelines.
📘 Regulatory Services for Mongolia
Regulatory & Product Registration Support – Mongolia
We assist pharmaceutical, nutraceutical, and cosmetic companies through every stage of regulatory submission and product approval in Mongolia, ensuring smooth market access and full compliance with MMA requirements.
📘 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 as per MMA Mongolia regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Mongolia.
• Assistance with preparation of quality, safety, and stability data as per MMA and ICH guidelines.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in MMA-approved CROs.
• Preparation of BE study protocols and reports according to WHO and MMA requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods in line with ICH Q2(R2).
• Preparation of AMV documentation for submission and routine QC.
🧾 Regulatory Consultancy & Compliance
• Strategic regulatory guidance for market entry into Mongolia.
• Support with import/export licenses, MMA inspections, renewals, and post-approval compliance.
• Continuous updates on MMA Mongolia regulatory changes to ensure ongoing product compliance.
🧪 Research & Development (R&D) Services – Mongolia
Our R&D services support product development, analytical validation, and quality assurance activities in accordance with MMA and international standards.
💊 Formulation Development
• Development and optimization of oral, topical, and injectable dosage forms.
• Stability testing under Mongolia’s climatic conditions to ensure product efficacy.
🧫 Analytical R&D Services
• Analytical method development, assay, dissolution, impurity profiling, and stability studies.
• QC method development and transfer to partner laboratories following MMA guidelines.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs including manufacturing, QC, and stability data.
• Submission-ready documentation compliant with MMA Mongolia requirements.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols, final study reports, and safety documentation.
• Toxicology studies following OECD and WHO principles for regulatory submission.
🌏 Why Choose Us for the Mongolia Market
• Experienced Regulatory Experts – Knowledgeable in MMA, ICH, and WHO frameworks.
• End-to-End Regulatory Support – From dossier compilation to post-approval lifecycle management.
• Regional Expertise – Experience across MENA, ASEAN, and East Asia markets.
• Timely Documentation – Streamlined preparation for faster MMA review and approval.
• Customized Regulatory Strategy – Tailored approach per product type and category.
📘 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
#DossierMongolia #DMFMongolia #DrugMasterFileMongolia #CTDMongolia #ACTDMongolia #RegulatorySubmissionMongolia #RegulatoryDocumentationMongolia #PharmaDossierMongolia #M4Mongolia #M5Mongolia #PDRMongolia #PSURMongolia #ClinicalTrialReportMongolia #CTReportMongolia #StabilityStudiesMongolia #ToxicityReportMongolia #PharmaValidationMongolia #ProcessValidationMongolia #BMRMongolia #MFRMongolia #PharmaManufacturingMongolia #PharmaQualityMongolia #PharmaComplianceMongolia
⚗️ Bioequivalence & Analytical Studies
#BEStudies #BioequivalenceStudy #PharmaBE #AnalyticalMethodValidation #AMV #PharmaAnalysis #MethodValidation #AssayValidation #DissolutionValidation #ReferenceStandardValidation #AMVAssay #AMVDissolution #AMVRS
#BEStudiesMongolia #BioequivalenceStudyMongolia #PharmaBEMongolia #AnalyticalMethodValidationMongolia #AMVMongolia #PharmaAnalysisMongolia #MethodValidationMongolia #AssayValidationMongolia #DissolutionValidationMongolia #ReferenceStandardValidationMongolia #AMVAssayMongolia #AMVDissolutionMongolia #AMVRSMongolia
🧪 Technology Transfer & Safety
#TechnologyTransfer #PharmaTechTransfer #MSDS #MaterialSafetyDataSheet #ProductTransfer #AnalyticalTransfer #MethodTransfer
#TechnologyTransferMongolia #PharmaTechTransferMongolia #MSDSMongolia #MaterialSafetyDataSheetMongolia #ProductTransferMongolia #AnalyticalTransferMongolia #MethodTransferMongolia
🌐 Top Pharma & Regulatory Hashtags – Mongolia
#PharmaMongolia #PharmaIndustryMongolia #DossierMongolia #DMFMongolia #CTDMongolia #ACTDMongolia #RegulatorySubmissionMongolia #PharmaDossierMongolia #PharmaComplianceMongolia #PharmaQualityMongolia #PharmaManufacturingMongolia #PharmaValidationMongolia #ProcessValidationMongolia #BMRMongolia #MFRMongolia #StabilityStudiesMongolia #PSURMongolia #ClinicalTrialReportMongolia #CTReportMongolia #ToxicityReportMongolia #BEStudiesMongolia #BioequivalenceStudyMongolia #PharmaBEMongolia #AMVMongolia #AnalyticalMethodValidationMongolia #AssayValidationMongolia #DissolutionValidationMongolia #AMVAssayMongolia #AMVDissolutionMongolia #AMVRSMongolia #TechnologyTransferMongolia #PharmaTechTransferMongolia #AnalyticalTransferMongolia #MethodTransferMongolia #MSDSMongolia