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

🇮🇪 Regulatory and Research Services for Ireland

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

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

Our operations fully comply with HPRA, EMA, EU Regulations, and ICH/WHO standards.

📘 Regulatory Services for Ireland

🇮🇪 Regulatory & Product Registration Support – Ireland (EU)

We support companies at all stages of dossier preparation, submission, and approval for entry into Ireland and the larger European Union market, aligned with:

✔ HPRA (Health Products Regulatory Authority)
✔ EMA
✔ EU Directives & Regulations
✔ ICH Guidelines

📘 Product Registration Services

• EU/Ireland Dossier Preparation & Registration

– EU-CTD dossier preparation for pharmaceuticals (Rx/OTC)
– Food supplement notification under FSAI (Food Safety Authority of Ireland)
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Support for Herbal, Ayurveda, Nutraceutical, Veterinary products
– Ingredient & claims check as per:
✔ (EC) 1925/2006 – Nutrition & Health Claims
✔ (EC) 2015/2283 – Novel Food
✔ (EC) 1223/2009 – Cosmetics Regulation

• Labeling & Packaging Compliance – Ireland/EU

– English-language label review for Irish market (mandatory)
– Packaging and artwork compliance with EU 1169/2011 Food Information Regulation
– Verification of claims, allergen declarations, warnings
– IFU/leaflet development for pharmaceuticals & supplements

📗 Drug Master File (DMF) / ASMF Services

– Compilation of EU-CTD Modules 2 & 3 for ASMF/DMF
– API documentation compliance as per HPRA and EMA
– Support for EDQM CEP certification
– Complete ICH Q8–Q10 documentation for EU regulatory acceptance

⚗️ Bioequivalence (BE) Study Support – EU/Ireland

– BE study design per EMA BE Guideline (CPMP/EWP/QWP/1401/98 Rev.1)
– Coordination with EU-accredited CROs
– Full BE study report preparation for HPRA/EMA
– Dissolution comparison and biowaiver support (where applicable)

🔬 Analytical Method Validation (AMV) Services

– Validation aligned to ICH Q2(R2)
– Method development and optimization (assay, dissolution, impurities)
– Preparation of validation protocols, raw data sheets, and final reports
– QC laboratory support for EU product release testing

🧾 Regulatory Consultancy & Compliance – Ireland

– Product classification guidance (pharma, food supplement, cosmetic)
– Importer/Distributor obligations under EU law
– GMP/GDP compliance support for Irish importing companies
– Variations, renewals, PSUR, and lifecycle management
– Regular updates on HPRA/EMA/EU regulatory changes

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

💊 Formulation Development

– Tablets, capsules, powders, liquids, syrups, injectables
– EU Zone II stability studies
– Product optimization for Irish market needs & EU climate conditions

🧫 Analytical R&D Services

– Assay, dissolution, impurity profiling
– QC method development & validation
– Comprehensive stability studies (real-time & accelerated)

📑 Product Development Reports (PDRs)

– PDRs developed in EU-CTD format
– Includes manufacturing process flow, control strategy & analytical data

🧍‍⚕️ Clinical Trial & Toxicology Support

– ICH-GCP (E6) compliant clinical protocols and final reports
– Toxicology data generation aligned to OECD guidelines
– Cosmetic PIF & CPSR (Cosmetic Product Safety Report) for EU compliance

🌏 Why Choose Us for the Ireland Market

• Specialists in HPRA, EMA, and EU regulatory systems
• End-to-end technical + regulatory support
• Strong experience across EU, US, ASEAN & ROW markets
• High-quality, fast submission-ready documentation (CTD/ASMF)
• Custom regulatory strategies tailored to Irish/EU product categories

📘 Regulatory & Dossier Documentation – Ireland/EU

Hashtags – Ireland & EU
#DossierIreland #DMFIreland #CTDIreland #EUCTD #ASMF #HPRA
#RegulatoryIreland #PharmaIreland #PharmaComplianceEU
#StabilityStudiesEU #PSUR #ClinicalTrialReportEU
#ProcessValidationEU #BMR #MFR #PharmaQualityEU

⚗️ Bioequivalence & Analytical Studies – Ireland/EU

#BEStudiesEU #BioequivalenceStudyEU #AnalyticalMethodValidationEU
#AMVEU #AssayValidationEU #DissolutionValidationEU

🧪 Technology Transfer & Safety – Ireland/EU

#TechnologyTransferEU #AnalyticalTransferEU #MethodTransferEU
#MSDSEU #PharmaTechTransferEU

🌐 Top Pharma & Regulatory Hashtags – Ireland & EU

#PharmaIreland #IrelandEU #HPRA #EUCTD #CPNP
#PharmaManufacturingEU #PharmaQualityEU #StabilityStudiesEU
#TechTransferEU #ClinicalTrialReportEU