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

🇸🇰 Regulatory and Research Services for Slovakia

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, provide complete regulatory and research solutions for pharmaceutical, nutraceutical, herbal, food supplement, and cosmetic companies aiming to enter the Slovak Republic (EU Market).

We ensure compliance with ŠÚKL, EMA, EU Directives/Regulations, and ICH/WHO international standards.

📘 Regulatory Services for Slovakia

🇸🇰 Regulatory & Product Registration Support – Slovakia (EU)

We assist companies through the entire regulatory cycle for entering the Slovakia and greater EU region, ensuring compliance with:

✔ ŠÚKL (State Institute for Drug Control)
✔ EMA
✔ EU Commission Regulations
✔ ICH standards

📘 Product Registration Services

• EU/Slovakia Dossier Preparation & Registration

– Preparation of EU-CTD dossiers for pharmaceutical (Rx/OTC) products
– Food supplement notification to the Public Health Authority of the Slovak Republic (ÚVZ SR)
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Regulatory support for Herbal, Ayurveda, Nutraceutical, Veterinary product entry
– Ingredient & claim compliance as per EU laws:

• (EC) 1925/2006 – Nutrition & Health

• (EC) 2015/2283 – Novel Food

• (EC) 1223/2009 – Cosmetics Regulation

• Labeling & Packaging Compliance – Slovakia/EU

– Slovak-language label review (mandatory for SK market)
– Compliance with EU Labeling Regulation 1169/2011
– Verification of nutritional claims, warnings & mandatory text
– Multilingual artwork and IFU/leaflet development

📗 Drug Master File (DMF) / ASMF Services

– Compilation of EU CTD Modules 2 & 3 for ASMF/DMF
– Support for API documentation under ŠÚKL & EMA requirements
– Preparation for CEP (EDQM Certificate of Suitability)
– Full technical documentation compliant with ICH Q8–Q10 and EU-GMP

⚗️ Bioequivalence (BE) Study Support – EU/Slovakia

– BE study design per EMA BE Guidelines
– Coordination with accredited EU CROs (EEA region)
– Preparation of complete BE reports for submission to ŠÚKL and EMA

🔬 Analytical Method Validation (AMV) Services

– Validation as per ICH Q2(R2)
– Method development & validation documentation
– Analytical QC support for pharmaceuticals & food supplements
– Dissolution, assay, impurity, and stability method validation

🧾 Regulatory Consultancy & Compliance

– Support for import requirements, local representation & EU regulatory pathways
– GMP/GDP documentation and audit support for Slovak importers
– Post-approval updates, variations & renewal submissions
– Continuous regulatory monitoring of ŠÚKL + EMA + EU Commission updates

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

💊 Formulation Development

– Tablets, capsules, liquids, syrups, powders, injectables
– EU climate zone stability testing (ICH Q1A–Q1F)
– Bioavailability & performance optimization for EU conditions

🧫 Analytical R&D Services

– Assay, dissolution, impurity profiling
– QC method development
– Real-time and accelerated stability testing

📑 Product Development Reports (PDRs)

– Full PDRs as per EU-CTD structure
– Includes manufacturing process, analytical data, & stability summary

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocol and report preparation in line with ICH-GCP E6(R2)
– Toxicology evaluations per OECD guidelines
– Cosmetic safety documentation (PIF) & CPSR support for EU cosmetic compliance

🌏 Why Choose Us for the Slovakia Market

• Specialists in ŠÚKL, EMA, and EU regulatory frameworks
• Full end-to-end regulatory and technical support
• Experience with EU, ASEAN, US, and ROW markets
• Fast submission timelines with high-quality documentation
• Customized product-based regulatory strategies

📘 Regulatory & Dossier Documentation – Slovakia/EU

Hashtags – Slovakia & EU
#DossierSlovakia #DMFSlovakia #CTDSlovakia #EUCTD #ASMF #EDMF
#RegulatorySlovakia #ŠÚKL #PharmaSlovakia #RegulatoryEU
#PharmaComplianceEU #PharmaDossierEU #StabilityStudiesEU
#PSUR #CTReportEU #ToxicityReportEU #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Slovakia/EU

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

🧪 Technology Transfer & Safety – Slovakia/EU

#TechnologyTransferEU #PharmaTechTransferEU #MethodTransferEU
#AnalyticalTransferEU #MSDSEU

🌐 Top Pharma & Regulatory Hashtags – Slovakia & EU

#PharmaSlovakia #SlovakiaEU #RegulatoryEU #ŠÚKL #EUCTD #ASMF
#PharmaManufacturingEU #PharmaQualityEU #ProcessValidationEU
#StabilityStudiesEU #ClinicalTrialReportEU #TechTransferEU