Regulatory And Research Services for Regulatory-Services-Coverage-by-Italy-Market
🇮🇹 Regulatory and Research Services for Italy
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, offer comprehensive regulatory and research services for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Italian (EU) market.
Our services comply with AIFA, Italian Ministry of Health, ISS, EMA, EU legislation, and ICH/WHO guidelines.
📘 Regulatory Services for Italy
🇮🇹 Regulatory & Product Registration Support – Italy (EU)
We support companies across the entire process of registration and market entry in Italy, ensuring compliance with:
✔ AIFA – Italian Medicines Agency
✔ Ministero della Salute – Food Supplements & Cosmetics
✔ ISS – Technical Scientific Institute (Scientific evaluation)
✔ EMA – EU Centralized Procedures
✔ EU EudraLex Framework
✔ ICH Quality/Safety/Efficacy Guidelines
📘 Product Registration Services
• Italy/EU Dossier Preparation & Submission
– EU-CTD dossier preparation for pharmaceutical products (Rx/OTC)
– Food supplement registration/notification via Italian Ministry of Health (NSIS) portal
– Cosmetic product notification through CPNP (EU Cosmetic Portal)
– Registration support for Herbal, Ayurveda, Nutraceutical & Veterinary products
– Ingredient & claims verification as per:
✔ EU Regulation 1925/2006
✔ EU Novel Food Regulation 2015/2283
✔ EU Cosmetics Regulation 1223/2009
✔ Italian Decrees for Botanicals (BELFRIT list)
• Italy/EU Label & Packaging Compliance
– Mandatory Italian-language labeling
– Compliance with EU 1169/2011 and Italian-specific labeling rules
– Verification of claims, allergens, warnings
– Leaflet, IFU & artwork preparation according to Italian requirements
📗 Drug Master File (DMF) / ASMF Services
– EU-CTD Modules 2 & 3 compilation
– API documentation for AIFA & EMA compliance
– CEP (EDQM) bridging and validation
– ICH Q8/Q9/Q10-based API technical documentation
– Support for manufacturers entering Italy/EU supply chains
⚗️ Bioequivalence (BE) Study Support – EU/Italy
– BE study protocol design per EMA BE Guidelines
– Coordination with EU/EEA-approved CROs
– Preparation of BE reports tailored for AIFA
– Biowaiver (BCS I/III) justification support
🔬 Analytical Method Validation (AMV) Services
– AMV according to ICH Q2(R2)
– Assay, dissolution, impurities, stability validations
– AMV documentation (protocol + final report)
– QC technical support for Italian/EU release testing
🧾 Regulatory Consultancy & Compliance – Italy
– Classification support for medicine / supplement / cosmetic / veterinary
– Italian MAH (Marketing Authorization Holder) roles & responsibilities
– GMP/GDP compliance for Italian distributors & importers
– Variations, renewals, PSUR, RMP management
– Monitoring of AIFA, ISS, EMA & Italian Ministry of Health regulations
🧪 Research & Development (R&D) Services – Italian Market
💊 Formulation Development
– Tablets, capsules, syrups, liquids, powders, injectables
– Stability studies under EU Zone II (Mediterranean climate)
– Product optimization for Italian market characteristics
🧫 Analytical R&D Services
– Method development & validation
– Impurity profiling, assay & dissolution
– Real-time & accelerated stability testing
📑 Product Development Reports (PDRs)
– Preparation of PDR in EU-CTD format
– Includes analytical results, manufacturing details & stability data
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical trial protocols & CSR per ICH-GCP (E6)
– Support with AIFA clinical trial submissions
– Toxicology assessment per OECD guidelines
– Cosmetic compliance documentation:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report
🌏 Why Choose Us for the Italy Market
• Expertise in AIFA, ISS, Ministry of Health & EMA regulatory pathways
• End-to-end regulatory + technical documentation support
• Strong experience in EU, US, GCC, ASEAN & ROW markets
• Fast & compliant CTD/ASMF dossier preparation
• Tailored solutions for pharma, supplements & cosmetics in Italy
📘 Regulatory & Dossier Documentation – Italy/EU
Hashtags – Italy & EU
#DossierItaly #DMFItaly #CTDItaly #AIFA
#PharmaItaly #RegulatoryItaly #PharmaComplianceEU
#FoodSupplementItaly #CosmeticsItaly #VeterinaryItaly
#StabilityStudiesEU #PSUR #ClinicalTrialItaly #MFR #BMR
⚗️ Bioequivalence & Analytical Studies – Italy/EU
#BEStudiesEU #BioequivalenceEU #AnalyticalMethodValidationEU
#AMVEU #DissolutionValidationEU #AssayValidationEU
🧪 Technology Transfer & Safety – Italy/EU
#TechnologyTransferEU #PharmaTechTransferEU
#AnalyticalTransferEU #MethodTransferEU #MSDSEU
🌐 Top Pharma & Regulatory Hashtags – Italy
#PharmaItaly #ItalyRegulatory #EMA #AIFA #EUCTD
#ClinicalTrialItaly #StabilityStudiesItaly #TechTransferEU