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

🇨🇾 Regulatory and Research Services for Cyprus

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

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

Our services comply with the Pharmaceutical Services of Cyprus, Cyprus MOH, EMA, and all applicable EU/ICH/WHO guidelines.

📘 Regulatory Services for Cyprus

🇨🇾 Regulatory & Product Registration Support – Cyprus (EU)

We support companies through the full regulatory process in Cyprus under:

✔ Pharmaceutical Services – Ministry of Health (Cyprus)
✔ Cyprus Licensing Authority for Medicinal Products
✔ Cyprus National Competent Authority (NCA)
✔ State General Laboratory (Food Supplements & Safety)
✔ EMA – EU Centralized Procedures
✔ EU EudraLex
✔ ICH Q/S/E Guidelines

📘 Product Registration Services

• Cyprus/EU Dossier Preparation & Submission

– Preparation of EU-CTD dossiers for pharmaceuticals (Rx/OTC)
– Food supplement notification to the Cyprus MOH + State Lab
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Registration support for:
✔ Herbal & traditional products
✔ Nutraceuticals
✔ Veterinary medicines
– Compliance with:
✔ EU Regulation 1925/2006 (supplements)
✔ EU Novel Food Regulation 2015/2283
✔ EU Cosmetics Regulation 1223/2009
✔ Cyprus-specific amendments & safety requirements

• Cyprus/EU Label & Packaging Compliance

– Mandatory Greek and/or English language labeling
– Compliance with EU 1169/2011 (Food Information Regulation)
– Review of claims, warnings, allergen statements
– IFU/leaflet & packaging artwork creation as per Cyprus/EU norms

📗 Drug Master File (DMF) / ASMF Services

– Preparation of EU-CTD Modules 2 & 3
– ASMF/DMF submission aligned with Cyprus MOH & EMA
– CEP (EDQM) bridging for API acceptance
– ICH Q8–Q10-compliant quality documentation
– Support for API manufacturers supplying to Cyprus/EU markets

⚗️ Bioequivalence (BE) Study Support – EU/Cyprus

– BE study design as per EMA BE Guidelines
– Coordination with EU-certified CROs
– Full BE report preparation for Cyprus MOH reviews
– Biowaiver justification (BCS Class I/III APIs)

🔬 Analytical Method Validation (AMV) Services

– AMV validation according to ICH Q2(R2)
– Assay, impurity, dissolution & stability validation
– Preparation of AMV protocols + raw data + validation reports
– QC method transfer support for Cyprus/EU markets

🧾 Regulatory Consultancy & Compliance – Cyprus

– Classification: medicine / supplement / cosmetic / veterinary
– Guidance for Cyprus MAH (Marketing Authorization Holder)
– GMP/GDP compliance for Cyprus importers & distributors
– Post-approval: variations, renewals, safety reports
– Monitoring of Cyprus MOH & EMA regulatory updates

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

💊 Formulation Development

– Tablets, capsules, liquid orals, powders, injectables
– Stability studies under EU Zone II Mediterranean conditions
– Formulation tuning for Cyprus market regulatory needs

🧫 Analytical R&D Services

– Method development & validation
– Assay, impurity profile, dissolution
– Stability studies (accelerated + real time)

📑 Product Development Reports (PDRs)

– Full PDRs prepared in EU-CTD format
– Includes development summary, QC methods & stability results

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocols & CSRs as per ICH-GCP (E6)
– Submission support to Cyprus MOH for clinical studies
– Toxicology dossiers per OECD guidelines
– Cosmetic safety documentation:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report

🌏 Why Choose Us for the Cyprus Market

• Expertise in Cyprus MOH, EMA & EU regulatory systems
• End-to-end registration, compliance & dossier support
• Proven global experience: EU, US, GCC, ASEAN & ROW
• Fast & compliant CTD/DMF/AMV preparation
• Tailored regulatory strategies for Cyprus & Pan-EU opportunities

📘 Regulatory & Dossier Documentation – Cyprus/EU

Hashtags – Cyprus & EU
#DossierCyprus #DMFCyprus #CTDCyprus
#PharmaCyprus #RegulatoryCyprus #CyprusMOH
#CosmeticsCyprus #FoodSupplementCyprus #VeterinaryCyprus
#EUCTD #PharmaComplianceEU #StabilityStudiesEU #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Cyprus/EU

#BEStudiesEU #BioequivalenceEU #AMVEU
#AssayValidationEU #DissolutionValidationEU

🧪 Technology Transfer & Safety – Cyprus/EU

#TechnologyTransferEU #AnalyticalTransferEU
#MethodTransferEU #MSDSEU #PharmaTechTransferEU