🇮🇹 Bioavailability & Bioequivalence (BA/BE) Studies Services for Italy
🇮🇹 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
Zoesoe Exports Pvt Ltd – Your Trusted Regulatory Partner for EU REACH & CLP Compliance in the Italian Market
Zoesoe Exports Pvt Ltd offers comprehensive Safety Data Sheet (SDS) services tailored specifically to meet the mandatory requirements of the European Union (EU), ensuring full compliance for products placed on the market in Italy. We guarantee your SDS (Scheda Dati di Sicurezza) is accurate, compliant with the latest EU standards, and adheres to the national language mandate and notification fee requirements.
🇮🇹 Why SDS Is Mandatory in Italy
Italy directly implements all EU chemical legislation. Compliance is overseen by the Ministry of Health and the Istituto Superiore di Sanità (ISS).
REACH Regulation (EC) No 1907/2006: Sets the mandatory 16-section structure and content of the SDS (latest format via Regulation (EU) 2020/878, mandatory since January 2023).
CLP Regulation (EC) No 1272/2008: Governs GHS-based classification, labelling, and packaging of substances and mixtures.
Annex VIII to CLP: Mandates Poison Centre Notification (PCN) to the appointed Italian national body (ISS), supported by the Unique Formula Identifier (UFI).
National Fee: Italy is one of the few EU countries that charges a fee (€50 per year) for Poison Centre Notification, irrespective of the number of notifications.
A compliant SDS (Scheda Dati di Sicurezza) for the Italian market must be:
Prepared as per the EU Regulation (EU) 2020/878 format.
Written entirely in Italian (Italiano), the official language.
Required to include the Unique Formula Identifier (UFI) for hazardous mixtures in Section 1.
PCN-ready to support mandatory submission and fee payment to the ISS.
🇮🇹 Our SDS Services for Italy (EU REACH/CLP Compliant)
1. SDS Preparation (EU 2020/878 Compliant)
We create a complete, 16-section, EU-compliant SDS (Scheda Dati di Sicurezza) for:
Industrial Chemicals & Mixtures
Consumer Products (paints, detergents, adhesives)
Pharmaceutical Raw Materials & Excipients
Our Italian SDS includes:
Hazard classification compliant with the CLP Regulation.
Composition and CAS verification, including the mandatory UFI code (for hazardous mixtures) in Section 1.1.
Inclusion of national regulatory references applicable in Italy, such as local Occupational Exposure Limit Values (OELs) and specific decrees (Sections 8 and 15).
eSDS (Extended Safety Data Sheet) preparation, including Exposure Scenarios (ES), where mandated by REACH.
2. SDS Review & Gap Analysis (PCN & Fee Check)
We review your existing EU SDS/MSDS for Italian market readiness:
Compliance with the latest EU Regulation (EU) 2020/878 content and format standards.
Consistency in CLP classification and accurate Italian terminology.
Completeness, including all 16 sections, UFI, and verification of compliance with the PCN fee payment procedure.
3. SDS Localisation for Italy
We adapt your existing EU-compliant master SDS (e.g., English or German) specifically for the Italian market:
Mandatory, technically precise translation into Italian.
Inclusion of Italian-specific regulatory references and proper use of national OELs in Section 8 and 15.
⚗️ Bioequivalence & Analytical Studies – Italy/EU
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🧪 Technology Transfer & Safety – Italy/EU
#TechnologyTransferEU #PharmaTechTransferEU
#AnalyticalTransferEU #MethodTransferEU #MSDSEU
🌐 Top Pharma & Regulatory Hashtags – Italy
#PharmaItaly #ItalyRegulatory #EMA #AIFA #EUCTD
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