Regulatory And Research Services for Regulatory-Services-Coverage-by-Hungary-Market
🇭🇺 Regulatory and Research Services for Hungary
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, food supplement, and cosmetic companies aiming to enter the Hungary market.
Our services ensure full compliance with OGYÉI (Hungarian National Institute of Pharmacy & Nutrition) regulations, European Medicines Agency (EMA) requirements, EU Directives/Regulations, and international ICH/WHO guidelines.
📘 Regulatory Services for Hungary
🇭🇺 Regulatory & Product Registration Support – Hungary & EU
We assist companies with regulatory submissions, product registrations, and market access in Hungary, ensuring full compliance with EU and Hungarian national requirements.
📘 Product Registration Services
• EU/Hungary Dossier Preparation & Submission
– Registration dossier preparation for pharmaceutical (Rx/OTC) products
– Food supplement (Nutraceutical) notification to OGYÉI
– Cosmetic product notification through CPNP (EU Cosmetic Portal)
– Herbal/Ayurveda/HPMC products compliance review under EU rules
– Veterinary product registration support based on EMA/CVMP guidelines
• Compliance With Hungary & EU Regulations
– Label and artwork compliance as per EU Regulation (EU) No 1169/2011 and OGYÉI norms
– Claims verification, ingredient acceptability, and mandatory statements
– Multilingual packaging support (Hungarian + EU languages)
📗 Drug Master File (DMF) / ASMF Services
– Compilation of EU-CTD (Modules 2–3) compliant ASMF/DMF
– Support for API documentation:
✓ Quality
✓ Manufacturing
✓ Stability
✓ CEP/EDMF requirements
– Compliance with EMA/ICH Q-series guidelines
⚗️ Bioequivalence (BE) Study Support – EU/Hungary
– BE study design as per EMA BE Guideline (CPMP/EWP/QWP/1401/98 Rev.1)
– Coordination with EU/EEA-accredited CROs
– Preparation of complete BE study dossiers for regulatory submission
🔬 Analytical Method Validation (AMV) Services
– Validation as per ICH Q2(R2) and EU GMP
– Preparation of method validation protocols & reports
– Support for QC laboratories and regulatory submissions
🧾 Regulatory Consultancy & Compliance
– End-to-end regulatory strategy for entering the Hungarian/EU market
– Support for import requirements, GMP dossier preparation, and regulatory audits
– Ongoing updates on EMA, EU Commission & OGYÉI regulatory changes
– Post-approval variations, renewals, and compliance management
🧪 Research & Development (R&D) Services – Hungary Market
💊 Formulation Development
– Development of tablets, capsules, syrups, powders, injectables
– EU-compliant stability studies (ICH Q1A-Q1E)
– Bioavailability and performance optimization for EU climate zones
🧫 Analytical R&D Services
– Assay, dissolution, impurity profiling
– QC method development
– Real-time & accelerated stability testing
📑 Product Development Reports (PDRs)
– EU-standard product development documentation
– Inclusion of process development, analytical results, and stability data
– Prepared as per EU-CTD requirements
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical trial documentation as per EMA/ICH GCP (E6)
– Toxicology assessments in line with OECD and EU REACH guidelines
– Support for cosmetics toxicology, safety reports (CPSR), and PIF requirements
🌏 Why Choose Us for the Hungary Market
• EU Regulatory Experts with experience in OGYÉI, EMA, and EU regulations
• Complete End-to-End Support from formulation to registration
• Experience Across Global Markets – ROW, ASEAN, US, EU
• Fast Regulatory Turnaround with streamlined dossier preparation
• Customized Strategies based on product classification & EU regulatory pathways
📘 Regulatory & Dossier Documentation (EU/Hungary)
Hashtags (Hungary & EU)
#DossierHungary #DMFHungary #CTDHungary #EUCTD #ASMF #EDMF
#RegulatorySubmissionEU #RegulatoryDocumentationEU #PharmaDossierEU
#PDR #PSUR #ClinicalTrialReportEU #StabilityStudiesEU
#ToxicityReportEU #PharmaValidationEU #ProcessValidationEU #BMR #MFR
#PharmaManufacturingEU #PharmaComplianceEU #OGYEI #EMA #EudraLex
⚗️ Bioequivalence & Analytical Studies (EU/Hungary)
#BEStudiesEU #BioequivalenceStudyEU #AnalyticalMethodValidationEU
#AMVEU #PharmaAnalysisEU #MethodValidationEU #AssayValidationEU
#DissolutionValidationEU
🧪 Technology Transfer & Safety (EU/Hungary)
#TechnologyTransferEU #PharmaTechTransferEU #MSDSEU
#MethodTransferEU #AnalyticalTransferEU
🌐 Top EU Pharma & Regulatory Hashtags
#PharmaEU #HungaryPharma #RegulatoryEU #EUCTD #ASMF #OGYEI
#PharmaComplianceEU #PharmaQualityEU #StabilityStudiesEU
#ClinicalTrialReportEU #BEStudiesEU #AMVEU #TechTransferEU