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

🇵🇱 Regulatory and Research Services for Poland

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research solutions to pharmaceutical, nutraceutical, herbal, food supplement, and cosmetic companies aiming to enter the Poland (EU) market.

Our services ensure full compliance with URPL (Urząd Rejestracji Produktów Leczniczych) regulations, European Medicines Agency (EMA) requirements, EU Directives/Regulations, and ICH/WHO guidelines.

📘 Regulatory Services for Poland

🇵🇱 Regulatory & Product Registration Support – Poland (EU)

We assist companies in preparing and submitting regulatory dossiers for entry into the Polish and wider EU market, ensuring compliance with URPL, EMA, and EU Commission standards.

📘 Product Registration Services

• EU/Poland Dossier Preparation & Registration

– Registration dossier (EU-CTD) for pharmaceuticals (Rx/OTC)
– Food supplement notification to GIS (Chief Sanitary Inspectorate)
– Cosmetic product notification through CPNP (EU Cosmetic Portal)
– Compliance assessment for Herbal, Ayurveda, Nutraceutical, Veterinary products
– EU ingredient compliance under Regulation (EC) 1925/2006, 2015/2283 (Novel Foods), and EC 1223/2009 (Cosmetics)

• Labeling & Packaging Compliance – Poland/EU

– EU-compliant labelling as per Regulation (EU) No 1169/2011
– Polish-language label review (mandatory for Poland market)
– Verification of nutritional, health, and cosmetic claims
– Regulatory artwork and leaflet compliance (Polish + EU languages)

📗 Drug Master File (DMF) / ASMF Services

– Compilation of EU-CTD Modules 2 & 3 for ASMF / EDMF submissions
– DMF support for APIs intended for EU/Polish manufacturers
– Compliance with EMA, ICH Q-series and EU GMP
– Assistance with CEP (EDQM certification) pathways

⚗️ Bioequivalence (BE) Study Support – EU/Poland

– BE study design as per EMA BE Guideline (CPMP/EWP/QWP/1401/98 Rev.1)
– Partnerships with EU-accredited CROs for BE studies
– Full BE report preparation for submission to URPL / EMA

🔬 Analytical Method Validation (AMV) Services

– ICH Q2(R2)-compliant analytical method validation
– Preparation of method validation protocols & reports
– Analytical support for API, finished dosage forms, and food supplements

🧾 Regulatory Consultancy & Compliance

– End-to-end regulatory support for Poland & EU market entry
– Importation requirements, GDP/GMP documentation, and URPL audits
– Management of post-approval variations, renewals, and periodic reporting
– Ongoing updates on EMA, URPL, and EU regulatory changes

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

💊 Formulation Development

– Development of tablets, capsules, liquids, syrups, powders, injectables
– EU stability studies as per ICH Q1A–Q1F
– Optimization for bioavailability & EU climate conditions (Zone II)

🧫 Analytical R&D Services

– Assay, dissolution, impurity profiling
– Method development and routine QC testing
– Stability studies (real-time & accelerated)

📑 Product Development Reports (PDRs)

– EU-CTD PDR documentation
– Full process development, analytical method details, stability data

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocols and reports compliant with EMA/ICH GCP (E6)
– Toxicology assessments as per OECD standards
– Support for cosmetic PIF preparation and CPSR (Cosmetic Product Safety Report)

🌏 Why Choose Us for the Poland Market

• Experienced in URPL, EMA, EU regulatory systems
• End-to-End Solutions: Development → Dossier → Approval → Compliance
• Strong Global Network across EU, ASEAN, US, and ROW markets
• Efficient Submission Processes ensuring faster approvals
• Customized Regulatory Strategies for each product class

📘 Regulatory & Dossier Documentation (Poland/EU)

Hashtags – Poland/EU
#DossierPoland #DMFPoland #CTDPoland #EUCTD #ASMF #EDMF
#RegulatorySubmissionPoland #RegulatoryEU #PharmaDossierEU
#PDR #PSUR #CTReport #StabilityStudiesEU #ToxicityReportEU
#PharmaValidationEU #BMR #MFR #PharmaCompliancePoland #URPL

⚗️ Bioequivalence & Analytical Studies (Poland/EU)

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

🧪 Technology Transfer & Safety (Poland/EU)

#TechnologyTransferEU #PharmaTechTransferEU #MSDSEU
#AnalyticalTransferEU #MethodTransferEU

🌐 Top Regulatory Hashtags – Poland & EU

#PharmaPoland #RegulatoryPoland #URPL #GIS #EUCTD #ASMF #CPNP
#PharmaQualityEU #PharmaManufacturingEU #ProcessValidationEU
#StabilityStudiesEU #BEStudiesEU #AMVEU #TechTransferEU