Regulatory And Research Services for Myanmar
🇲🇲 Regulatory and Research Services for Myanmar – 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 Myanmar market.
Our services ensure full compliance with the Food and Drug Administration (FDA) Myanmar, under the Ministry of Health, as well as WHO and ICH guidelines.
📘 Regulatory Services for Myanmar
Regulatory & Product Registration Support – Myanmar
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with FDA Myanmar, 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 FDA Myanmar regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Myanmar.
• Preparation of quality, safety, and stability documentation according to FDA Myanmar and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in FDA-approved CROs.
• Preparation of BE study protocols and reports according to WHO and FDA Myanmar requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods in compliance with ICH Q2(R2).
• Preparation of AMV protocols and reports for regulatory submission and routine QC.
🧾 Regulatory Consultancy & Compliance
• Strategic regulatory guidance for Myanmar market entry.
• Assistance with import/export licensing, FDA Myanmar inspections, and post-approval compliance.
• Ongoing updates on FDA Myanmar regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Myanmar
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with FDA Myanmar and international standards.
💊 Formulation Development
• Development and optimization of oral, topical, and injectable dosage forms.
• Stability studies designed for Myanmar’s climatic conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per FDA Myanmar requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for FDA Myanmar submission.
• Inclusion of formulation, manufacturing, QC, and stability data.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols and final reports for submission to FDA Myanmar.
• Toxicology and preclinical studies in accordance with OECD and WHO guidelines.
🌏 Why Choose Us for the Myanmar Market
• Experienced Regulatory Team – Experts in FDA Myanmar, WHO, and ICH frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across ASEAN and neighboring 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
#DossierMyanmar #DMFMyanmar #DrugMasterFileMyanmar #CTDMyanmar #ACTDMyanmar #RegulatorySubmissionMyanmar #RegulatoryDocumentationMyanmar #PharmaDossierMyanmar #M4Myanmar #M5Myanmar #PDRMyanmar #PSURMyanmar #ClinicalTrialReportMyanmar #CTReportMyanmar #StabilityStudiesMyanmar #ToxicityReportMyanmar #PharmaValidationMyanmar #ProcessValidationMyanmar #BMRMyanmar #MFRMyanmar #PharmaManufacturingMyanmar #PharmaQualityMyanmar #PharmaComplianceMyanmar
⚗️ Bioequivalence & Analytical Studies
#BEStudies #BioequivalenceStudy #PharmaBE #AnalyticalMethodValidation #AMV #PharmaAnalysis #MethodValidation #AssayValidation #DissolutionValidation #ReferenceStandardValidation #AMVAssay #AMVDissolution #AMVRS
#BEStudiesMyanmar #BioequivalenceStudyMyanmar #PharmaBEMyanmar #AnalyticalMethodValidationMyanmar #AMVMyanmar #PharmaAnalysisMyanmar #MethodValidationMyanmar #AssayValidationMyanmar #DissolutionValidationMyanmar #ReferenceStandardValidationMyanmar #AMVAssayMyanmar #AMVDissolutionMyanmar #AMVRSMyanmar
🧪 Technology Transfer & Safety
#TechnologyTransfer #PharmaTechTransfer #MSDS #MaterialSafetyDataSheet #ProductTransfer #AnalyticalTransfer #MethodTransfer
#TechnologyTransferMyanmar #PharmaTechTransferMyanmar #MSDSMyanmar #MaterialSafetyDataSheetMyanmar #ProductTransferMyanmar #AnalyticalTransferMyanmar #MethodTransferMyanmar
🌐 Top Pharma & Regulatory Hashtags – Myanmar
#PharmaMyanmar #PharmaIndustryMyanmar #DossierMyanmar #DMFMyanmar #CTDMyanmar #ACTDMyanmar #RegulatorySubmissionMyanmar #PharmaDossierMyanmar #PharmaComplianceMyanmar #PharmaQualityMyanmar #PharmaManufacturingMyanmar #PharmaValidationMyanmar #ProcessValidationMyanmar #BMRMyanmar #MFRMyanmar #StabilityStudiesMyanmar #PSURMyanmar #ClinicalTrialReportMyanmar #CTReportMyanmar #ToxicityReportMyanmar #BEStudiesMyanmar #BioequivalenceStudyMyanmar #PharmaBEMyanmar #AMVMyanmar #AnalyticalMethodValidationMyanmar #AssayValidationMyanmar #DissolutionValidationMyanmar #AMVAssayMyanmar #AMVDissolutionMyanmar #AMVRSMyanmar #TechnologyTransferMyanmar #PharmaTechTransferMyanmar #AnalyticalTransferMyanmar #MethodTransferMyanmar #MSDSMyanmar