SDS (Bezpečnostní list) Preparation & Review Services for The CZECH REPUBLIC

🇨🇿 Regulatory and Research Services for the Czech Republic

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, offer complete regulatory and research solutions for pharmaceutical, nutraceutical, herbal, food supplement, veterinary, and cosmetic companies targeting the Czech Republic (EU) market.

Our regulatory strategies fully comply with SÚKL, EMA, EU Directives, Czech national regulations, and ICH/WHO guidelines.

📘 Regulatory Services for the Czech Republic

🇨🇿 Regulatory & Product Registration Support – Czech Republic (EU)

We support companies through the full regulatory pathway for entry into the Czech Republic and broader EU market, ensuring compliance with:

✔ SÚKL – State Institute for Drug Control
✔ Ministry of Health of the Czech Republic
✔ EU EudraLex guidelines
✔ EMA
✔ ICH Q/S/E Guidelines

📘 Product Registration Services

• Czech Republic/EU Dossier Preparation & Registration

– EU-CTD dossier preparation for pharmaceuticals (Rx/OTC)
– Food supplement notification to the Czech Ministry of Health
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Regulatory support for Herbal, Ayurveda, Nutraceutical, Veterinary product entry
– Ingredient/claims compliance under:
✔ EU Regulation (EC) 1925/2006 (Nutrition & Health Claims)
✔ EU Novel Food Regulation (EU 2015/2283)
✔ EU Cosmetics Regulation (EC 1223/2009)

• Czech Republic/EU Label & Packaging Compliance

– Czech-language label review (mandatory for CZ market)
– Compliance with EU Regulation 1169/2011 (Food Information)
– Verification of allergens, health claims, safety warnings
– Artwork, IFU, and multilingual leaflet development

📗 Drug Master File (DMF) / ASMF Services

– Preparation of EU-CTD Modules 2 & 3 for ASMF/DMF
– API documentation compliant with SÚKL & EMA
– CEP (EDQM) dossier preparation and bridging
– Full ICH-compliant technical documentation for Czech/EU submissions

⚗️ Bioequivalence (BE) Study Support – EU/Czech Republic

– BE study protocol design per EMA guidelines
– Coordination with certified EU CROs
– BE report preparation for SÚKL/EMA
– Biowaiver justification support based on BCS classification

🔬 Analytical Method Validation (AMV) Services

– Validation per ICH Q2(R2)
– Method development & validation (assay, impurities, dissolution, RS)
– AMV protocol & validation report preparation
– QC support for manufacturers supplying the Czech/EU markets

🧾 Regulatory Consultancy & Compliance – Czech Republic

– Classification: medicine, supplement, cosmetic, veterinary
– Importer/MAH obligations under Czech/EU law
– GMP/GDP compliance support for Czech distributors
– Post-approval updates: variations, renewals, PSUR
– Regulatory monitoring for SÚKL + EU + EMA changes

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

💊 Formulation Development

– Tablets, capsules, syrups, powders, injectables
– EU Zone II stability studies
– Development tailored to Czech/European climatic conditions

🧫 Analytical R&D Services

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

📑 Product Development Reports (PDRs)

– EU-CTD format PDR documentation
– Includes analytical results, process design & stability data

🧍‍⚕️ Clinical Trial & Toxicology Support – Czech Republic

– Clinical trial protocol & CSR preparation per ICH-GCP (E6)
– Toxicology study preparation per OECD guidelines
– Cosmetic compliance:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report

🌏 Why Choose Us for the Czech Republic Market

• Experienced in SÚKL, EMA, EU regulatory systems
• End-to-end regulatory, technical & documentation support
• Global experience: EU, US, GCC, ASEAN, ROW
• High-quality CTD/ASMF dossier preparation
• Tailored solutions for pharmaceuticals, supplements, and cosmetics

📘 Regulatory & Dossier Documentation – Czech Republic/EU

Hashtags – Czech Republic & EU
#DossierCZ #DMFCZ #CTDCZ #SÚKL #RegulatoryCZ
#PharmaCzechRepublic #PharmaComplianceEU
#FoodSupplementCZ #CosmeticsCZ #VeterinaryCZ
#StabilityStudiesEU #PSUR #ClinicalTrialEU #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – CZ/EU

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

🧪 Technology Transfer & Safety – CZ/EU

#TechnologyTransferEU #MethodTransferEU #AnalyticalTransferEU
#MSDSEU #PharmaTechTransferEU

🌐 Top Pharma & Regulatory Hashtags – Czech Republic

#PharmaCZ #CzechRegulatory #SÚKL #EUCTD
#CPNPCZ #PharmaQualityEU #TechTransferEU
#ClinicalTrialCZ #StabilityStudiesCZ