Regulatory And Research Services for Regulatory-Services-Coverage-by-Slovenia-Market
🇸🇮 Regulatory and Research Services for Slovenia
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, provide full regulatory and research support to pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Slovenian (EU) market.
Our services align with JAZMP, UVHVVR, EMA, EU directives, and ICH/WHO standards.
📘 Regulatory Services for Slovenia
🇸🇮 Regulatory & Product Registration Support – Slovenia (EU)
We support companies in the entire regulatory and approval process for entering Slovenia, ensuring compliance with:
✔ JAZMP – Agency for Medicinal Products and Medical Devices
✔ UVHVVR – Food Safety & Veterinary Authority
✔ Ministry of Health (Slovenia)
✔ EMA – EU Centralized Procedures
✔ EU EudraLex Pharmaceutical Legislation
✔ ICH Q/S/E Guidelines
📘 Product Registration Services
• Slovenia/EU Dossier Preparation & Submission
– Preparation of EU-CTD dossiers for pharmaceuticals (Rx/OTC)
– Food supplement notification to UVHVVR
– Cosmetic product notification through CPNP (EU Cosmetic Portal)
– Regulatory support for Herbal, Ayurveda, Nutraceutical, Veterinary product compliance
– Ingredient & claims validation based on:
✔ EU Regulation 1925/2006
✔ EU Novel Food Regulation 2015/2283
✔ EU Cosmetics Regulation 1223/2009
✔ Slovenian national botanical & ingredient lists
• Slovenia/EU Label & Packaging Compliance
– Mandatory Slovenian-language (Slovene) labeling
– Compliance with EU 1169/2011 Food Information Regulation
– Allergen, warning & approved claim validation
– Artwork, IFU & leaflet development per Slovenian/EU regulations
📗 Drug Master File (DMF) / ASMF Services
– Preparation of EU-CTD Module 2 & 3 (ASMF/DMF)
– API documentation aligned with JAZMP & EMA requirements
– CEP (EDQM) bridging support
– ICH Q8/Q9/Q10 technical documentation
– Support for API manufacturers entering the Slovenian/EU supply chain
⚗️ Bioequivalence (BE) Study Support – EU/Slovenia
– BE study design per EMA guidelines
– Coordination with accredited CROs across the EU
– BE report preparation for JAZMP/EMA
– Biowaiver (BCS class I/III) justification
🔬 Analytical Method Validation (AMV) Services
– Validation per ICH Q2(R2)
– Assay, impurity profiling, dissolution & stability testing
– AMV protocols + full validation report creation
– QC testing support for Slovenian importers/manufacturers
🧾 Regulatory Consultancy & Compliance – Slovenia
– Classification support: medicine / supplement / cosmetic / veterinary
– MAH (Marketing Authorization Holder) responsibilities
– GMP/GDP compliance for Slovenian wholesalers & importers
– Variations, renewals, PSUR & lifecycle management
– Monitoring updates from JAZMP, EMA, EU Commission.
🧪 Research & Development (R&D) Services – Slovenia Market
💊 Formulation Development
– Tablets, capsules, liquids, powders, syrups, injectables
– Stability studies as per EU Zone II conditions
– Formulation optimization for Slovenian & EU requirements
🧫 Analytical R&D Services
– Method development & validation
– Impurity, assay, dissolution testing
– Stability studies (real-time & accelerated)
📑 Product Development Reports (PDRs)
– Complete EU-CTD format PDRs
– Includes manufacturing process, analytical methods & stability summaries
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical trial documentation following ICH-GCP (E6)
– Toxicology assessment per OECD guidelines
– Cosmetic compliance documentation:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report
🌏 Why Choose Us for the Slovenia Market
• Expertise in JAZMP, UVHVVR, EMA & EU regulatory pathways
• Complete regulatory, technical & documentation support
• Extensive global experience across EU, US, GCC, ASEAN, ROW
• Fast & compliant CTD/ASMF preparation
• Customized strategies tailored for Slovenian/EU markets
📘 Regulatory & Dossier Documentation – Slovenia/EU
Hashtags – Slovenia & EU
#DossierSlovenia #DMFSlovenia #CTDSlovenia #JAZMP
#RegulatorySlovenia #PharmaSlovenia
#FoodSupplementSlovenia #CosmeticsSlovenia #VeterinarySlovenia
#PharmaComplianceEU #StabilityStudiesEU #PSUR #BMR #MFR
⚗️ Bioequivalence & Analytical Studies – Slovenia/EU
#BEStudiesEU #BioequivalenceEU #AMVEU
#AssayValidationEU #DissolutionValidationEU
🧪 Technology Transfer & Safety – Slovenia/EU
#TechnologyTransferEU #PharmaTechTransferEU
#AnalyticalTransferEU #MethodTransferEU #MSDSEU
🌐 Top Pharma & Regulatory Hashtags – Slovenia
#PharmaSlovenia #SloveniaRegulatory #EUCTD #EMA
#ClinicalTrialEU #StabilityStudiesSlovenia #TechTransferEU