Regulatory And Research Services for Bangladesh
Regulatory and Research Services for Bangladesh –Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research solutions to pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Bangladesh market. Our services are designed to ensure full compliance with Bangladesh’s National Drug Policy, DGDA regulations, and international standards.
Regulatory Services for Bangladesh
Regulatory & Product Registration Support – Bangladesh
We assist pharmaceutical, nutraceutical, and cosmetic companies at every stage of regulatory submission and product approval in Bangladesh, ensuring a smooth market entry and full compliance with DGDA guidelines.
📘 Product Registration Services
Preparation and submission of export registration dossiers for prescription (Rx) and OTC products.
Registration support for Herbal, Ayurveda, Nutraceutical, Veterinary, and Cosmetic products.
Guidance on local labeling, packaging requirements, and product information leaflets.
📗 Drug Master File (DMF) Services
Compilation of CTD/ACTD-compliant DMFs for APIs intended for Bangladesh registration.
Support in API regulatory documentation covering quality, safety, and stability data.
⚗️ Bioequivalence (BE) Study Support
Design and coordination of BE studies in DGDA-approved CROs.
Full BE report preparation in accordance with WHO and Bangladesh regulatory guidelines.
🔬 Analytical Method Validation (AMV) Services
Validation of analytical methods as per ICH Q2(R2) guidelines.
Preparation of AMV documentation for regulatory submission and routine QC support.
🧾 Regulatory Consultancy & Compliance
End-to-end regulatory guidance for export or local market entry in Bangladesh.
Assistance with import/export permissions, DGDA inspections, and post-approval compliance.
Continuous updates on DGDA and WHO regulatory changes to ensure ongoing product compliance.
🧪 Research & Development (R&D) Services – Bangladesh
Our R&D services support your product development, validation, and quality assurance requirements to meet Bangladesh DGDA standards.
💊 Formulation Development
Development of tablets, capsules, syrups, powders, and injectables.
Optimization for stability, bioavailability, and efficacy to meet local conditions.
🧫 Analytical R&D Services
Assay, dissolution, impurity profiling, and stability testing.
Quality control method development and routine analytical testing.
📑 Product Development Reports (PDRs)
Preparation of comprehensive PDRs for regulatory submission.
Inclusion of manufacturing process, QC methods, and stability data in line with DGDA requirements.
🧍⚕️ Clinical Trial & Toxicology Support
Preparation of clinical trial protocols and final study reports.
Toxicological evaluation following OECD and DGDA guidelines.
🌏 Why Choose Us for the Bangladesh Market
Experienced Team – Experts in DGDA, WHO, and ICH regulatory frameworks.
End-to-End Support – From formulation development to market registration and compliance.
Global Exposure – Proven expertise in ROW, ASEAN, US, and EU regulatory environments.
Timely Submissions – Streamlined processes for faster approvals.
Custom Solutions – Tailored strategies for your product type, market segment, and regulatory pathway.
📘 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
#DossierBangladesh #DMFBangladesh #DrugMasterFileBangladesh #CTDBangladesh #ACTDBangladesh #RegulatorySubmissionBangladesh #RegulatoryDocumentationBangladesh #PharmaDossierBangladesh #M4Bangladesh #M5Bangladesh #PDRBangladesh #PSURBangladesh #ClinicalTrialReportBangladesh #CTReportBangladesh #StabilityStudiesBangladesh #ToxicityReportBangladesh #PharmaValidationBangladesh #ProcessValidationBangladesh #BMRBangladesh #MFRBangladesh #PharmaManufacturingBangladesh #PharmaQualityBangladesh #PharmaComplianceBangladesh
⚗️ Bioequivalence & Analytical Studies
#BEStudies #BioequivalenceStudy #PharmaBE #AnalyticalMethodValidation #AMV #PharmaAnalysis #MethodValidation #AssayValidation #DissolutionValidation #ReferenceStandardValidation #AMVAssay #AMVDissolution #AMVRS
#BEStudiesBangladesh #BioequivalenceStudyBangladesh #PharmaBEBangladesh #AnalyticalMethodValidationBangladesh #AMVBangladesh #PharmaAnalysisBangladesh #MethodValidationBangladesh #AssayValidationBangladesh #DissolutionValidationBangladesh #ReferenceStandardValidationBangladesh #AMVAssayBangladesh #AMVDissolutionBangladesh #AMVRSBangladesh
🧪 Technology Transfer & Safety
#TechnologyTransfer #PharmaTechTransfer #MSDS #MaterialSafetyDataSheet #ProductTransfer #AnalyticalTransfer #MethodTransfer
#TechnologyTransferBangladesh #PharmaTechTransferBangladesh #MSDSBangladesh #MaterialSafetyDataSheetBangladesh #ProductTransferBangladesh #AnalyticalTransferBangladesh #MethodTransferBangladesh
Top Pharma & Regulatory Hashtags – Bangladesh
#PharmaBangladesh #PharmaIndustryBangladesh #DossierBangladesh #DMFBangladesh #CTDBangladesh #ACTDBangladesh #RegulatorySubmissionBangladesh #PharmaDossierBangladesh #PharmaComplianceBangladesh #PharmaQualityBangladesh #PharmaManufacturingBangladesh #PharmaValidationBangladesh #ProcessValidationBangladesh #BMRBangladesh #MFRBangladesh #StabilityStudiesBangladesh #PSURBangladesh #ClinicalTrialReportBangladesh #CTReportBangladesh #ToxicityReportBangladesh #BEStudiesBangladesh #BioequivalenceStudyBangladesh #PharmaBEBangladesh #AMVBangladesh #AnalyticalMethodValidationBangladesh #AssayValidationBangladesh #DissolutionValidationBangladesh #AMVAssayBangladesh #AMVDissolutionBangladesh #AMVRSBangladesh #TechnologyTransferBangladesh #PharmaTechTransferBangladesh #AnalyticalTransferBangladesh #MethodTransferBangladesh #MSDSBangladesh