Regulatory And Research Services for Regulatory-Services-Coverage-by-Greece-Market

🇬🇷 Regulatory and Research Services for Greece

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, provide complete regulatory and research support for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Greek (EU) market.

Our services ensure full compliance with EOF, EFET, EMA, EU pharma directives, Cosmetics Regulation, and ICH/WHO standards.

📘 Regulatory Services for Greece

🇬🇷 Regulatory & Product Registration Support – Greece (EU)

We support companies throughout the regulatory submission and market-entry process according to:

✔ EOF – Hellenic National Organization for Medicines
✔ EFET – Hellenic Food Authority
✔ Ministry of Health Greece
✔ EMA – European Medicines Agency
✔ EU EudraLex Pharmaceutical Law
✔ ICH Q/S/E Guidelines

📘 Product Registration Services

• Greece/EU Dossier Preparation & Submission

– EU-CTD dossier preparation for pharmaceutical products (Rx/OTC)
– Food supplement notification to EFET (botanicals, vitamins, minerals)
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Regulatory support for Herbal, Ayurveda, Nutraceutical, Veterinary product entry
– Ingredient & claims compliance as per:
✔ EU Regulation 1925/2006 (Health & Nutrition Claims)
✔ EU Novel Food Regulation (EU 2015/2283)
✔ EU Cosmetics Regulation (EC 1223/2009)
✔ Greek-specific lists (botanicals, permissible substances)

• Greece/EU Label & Packaging Compliance

– Mandatory Greek-language labeling
– Compliance with EU 1169/2011 Food Information Regulation
– Validation of warnings, allergens & health claims
– IFU/leaflet and artwork preparation for Greek/EU packaging

📗 Drug Master File (DMF) / ASMF Services

– Preparation of EU-CTD Module 2 & 3 for ASMF/DMF submissions
– API documentation aligned with EOF & EMA
– CEP (EDQM) bridging support for Greece
– ICH Q8–Q10 compliant technical documentation
– Assistance for API suppliers entering the Greek/EU pharma market

⚗️ Bioequivalence (BE) Study Support – EU/Greece

– BE study protocol design per EMA guidelines
– Coordination with EU-accredited CROs
– BE study report preparation for EOF/EMA
– BCS-based biowaiver justification support

🔬 Analytical Method Validation (AMV) Services

– Method validation in accordance with ICH Q2(R2)
– Assay, dissolution, impurities & stability method validation
– AMV protocol + validation report preparation
– QC support for manufacturers and Greek/EU importers

🧾 Regulatory Consultancy & Compliance – Greece

– Classification support: pharma, supplement, cosmetic, veterinary
– Greek MAH (Marketing Authorization Holder) obligations
– GMP/GDP compliance for Greek distributors
– Variations, renewals, PSUR & lifecycle management
– Monitoring regulatory updates from EOF + EFET + EMA

🧪 Research & Development (R&D) Services – Greek Market

💊 Formulation Development

– Tablets, capsules, liquids, syrups, powders, injectables
– Stability studies as per EU Zone II (Mediterranean climate)
– Optimization for Greek market requirements

🧫 Analytical R&D Services

– Assay, dissolution, impurity profiling
– QC method development & validation
– Stability testing (real-time & accelerated)

📑 Product Development Reports (PDRs)

– EU-CTD format PDR documentation
– Includes manufacturing process, analytical methods & stability results

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documentation per ICH-GCP (E6)
– Support for EOF clinical trial submissions
– Toxicology reporting following OECD guidelines
– Cosmetic compliance documentation:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report

🌏 Why Choose Us for the Greece Market

• Specialists in EOF, EFET, EMA & EU regulatory pathways
• End-to-end regulatory, documentation & technical support
• Strong experience across EU, US, GCC, ASEAN & ROW markets
• Fast & compliant CTD/ASMF preparation
• Tailored strategies for Greek-specific regulatory requirements

📘 Regulatory & Dossier Documentation – Greece/EU

Hashtags – Greece & EU
#DossierGreece #DMFGreece #CTDGreece #EOF
#RegulatoryGreece #PharmaGreece #CosmeticsGreece
#FoodSupplementGreece #VeterinaryGreece #PharmaComplianceEU
#StabilityStudiesEU #PSUR #ClinicalTrialGreece #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Greece/EU

#BEStudiesEU #BioequivalenceEU #AMVEU
#AssayValidationEU #DissolutionValidationEU

🧪 Technology Transfer & Safety – Greece/EU

#TechnologyTransferEU #MethodTransferEU
#AnalyticalTransferEU #MSDSEU #PharmaTechTransferEU

🌐 Top Pharma & Regulatory Hashtags – Greece

#PharmaGreece #GreeceRegulatory #EUCTD #EMA #EOF
#ClinicalTrialEU #CosmeticsGreece #FoodSupplementGreece
#StabilityStudiesGreece #TechTransferEU