Regulatory And Research Services for Turkey
🇹🇷 Regulatory and Research Services for Turkey – 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 Turkey market.
Our services ensure full compliance with the Turkish Medicines and Medical Devices Agency (TMMDA / TITCK), as well as WHO and ICH guidelines.
📘 Regulatory Services for Turkey
Regulatory & Product Registration Support – Turkey
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with TMMDA, 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 TMMDA regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Turkey.
• Support in preparing quality, safety, and stability documentation in line with TMMDA and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in TMMDA-approved CROs.
• Preparation of BE study protocols and reports according to WHO and TMMDA 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 Turkey market.
• Assistance with import/export licensing, TMMDA inspections, renewals, and post-approval compliance.
• Continuous updates on TMMDA regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Turkey
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with TMMDA and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Turkey’s climatic conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per TMMDA requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to TMMDA.
• 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 TMMDA submission.
🌏 Why Choose Us for the Turkey Market
• Experienced Regulatory Experts – Skilled in TMMDA, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across Europe, Middle East, and Central Asia.
• 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
#DossierTurkey #DMFTurkey #DrugMasterFileTurkey #CTDTurkey #ACTDTurkey #RegulatorySubmissionTurkey #RegulatoryDocumentationTurkey #PharmaDossierTurkey #M4Turkey #M5Turkey #PDRTurkey #PSURTurkey #ClinicalTrialReportTurkey #CTReportTurkey #StabilityStudiesTurkey #ToxicityReportTurkey #PharmaValidationTurkey #ProcessValidationTurkey #BMRTurkey #MFRTurkey #PharmaManufacturingTurkey #PharmaQualityTurkey #PharmaComplianceTurkey
⚗️ Bioequivalence & Analytical Studies
#BEStudies #BioequivalenceStudy #PharmaBE #AnalyticalMethodValidation #AMV #PharmaAnalysis #MethodValidation #AssayValidation #DissolutionValidation #ReferenceStandardValidation #AMVAssay #AMVDissolution #AMVRS
#BEStudiesTurkey #BioequivalenceStudyTurkey #PharmaBETurkey #AnalyticalMethodValidationTurkey #AMVTurkey #PharmaAnalysisTurkey #MethodValidationTurkey #AssayValidationTurkey #DissolutionValidationTurkey #ReferenceStandardValidationTurkey #AMVAssayTurkey #AMVDissolutionTurkey #AMVRSTurkey
🧪 Technology Transfer & Safety
#TechnologyTransfer #PharmaTechTransfer #MSDS #MaterialSafetyDataSheet #ProductTransfer #AnalyticalTransfer #MethodTransfer
#TechnologyTransferTurkey #PharmaTechTransferTurkey #MSDSTurkey #MaterialSafetyDataSheetTurkey #ProductTransferTurkey #AnalyticalTransferTurkey #MethodTransferTurkey
🌐 Top Pharma & Regulatory Hashtags – Turkey
#PharmaTurkey #PharmaIndustryTurkey #DossierTurkey #DMFTurkey #CTDTurkey #ACTDTurkey #RegulatorySubmissionTurkey #PharmaDossierTurkey #PharmaComplianceTurkey #PharmaQualityTurkey #PharmaManufacturingTurkey #PharmaValidationTurkey #ProcessValidationTurkey #BMRTurkey #MFRTurkey #StabilityStudiesTurkey #PSURTurkey #ClinicalTrialReportTurkey #CTReportTurkey #ToxicityReportTurkey #BEStudiesTurkey #BioequivalenceStudyTurkey #PharmaBETurkey #AMVTurkey #AnalyticalMethodValidationTurkey #AssayValidationTurkey #DissolutionValidationTurkey #AMVAssayTurkey #AMVDissolutionTurkey #AMVRSTurkey #TechnologyTransferTurkey #PharmaTechTransferTurkey #AnalyticalTransferTurkey #MethodTransferTurkey #MSDSTurkey