Regulatory And Research Services for Regulatory-Services-Coverage-by-Sweden-Market
🇸🇪 Regulatory and Research Services for Sweden
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, offer comprehensive regulatory and research support to pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies aiming to enter the Sweden (EU) market.
All services comply with Läkemedelsverket, EMA, EU Directives/Regulations, and ICH/WHO standards.
📘 Regulatory Services for Sweden
🇸🇪 Regulatory & Product Registration Support – Sweden (EU)
We support companies throughout the regulatory approval and market entry process for Sweden, ensuring compliance with:
✔ Läkemedelsverket – Swedish Medical Products Agency (MPA)
✔ EMA – European Medicines Agency
✔ Livsmedelsverket – Swedish Food Agency
✔ EU Pharma Law (EudraLex)
✔ ICH Q/S/E guidelines
📘 Product Registration Services
• EU/Sweden Dossier Preparation & Product Approvals
– EU-CTD dossier preparation for pharmaceuticals (Rx/OTC)
– Food supplement compliance & notification to Livsmedelsverket
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Support for Herbal, Ayurveda, Nutraceutical, Veterinary product classification
– Ingredient & claim compliance with:
✔ Regulation (EC) 1925/2006 – Nutrition & Health
✔ Regulation (EC) 2015/2283 – Novel Foods
✔ Regulation (EC) 1223/2009 – Cosmetics
• Sweden/EU Label & Packaging Compliance
– Swedish-language label review (mandatory for Sweden market)
– Compliance with EU Regulation 1169/2011
– Verification of allergens, warnings, mandatory statements
– Multilingual label, artwork & IFU/leaflet preparation
📗 Drug Master File (DMF) / ASMF Services
– Preparation of Modules 2 & 3 of EU-CTD for ASMF/DMF
– API documentation aligned with Läkemedelsverket & EMA
– Support for CEP (Certificate of Suitability)
– ICH Q8/Q9/Q10-compliant technical documentation
– Assistance for API suppliers entering the Swedish/EU markets
⚗️ Bioequivalence (BE) Study Support – EU/Sweden
– BE study protocol design as per EMA BE Guideline
– Coordination with certified CROs across the European Economic Area
– Complete BE report writing for Läkemedelsverket/EMA
– Support for dissolution comparison & biowaiver submissions
🔬 Analytical Method Validation (AMV) Services
– ICH Q2(R2)-compliant validation
– Method development for assay, impurities, dissolution, stability
– AMV protocol, data sheets & validation report preparation
– QC technical support for routine testing & EU market release
🧾 Regulatory Consultancy & Compliance – Sweden
– Regulatory pathway assessment for pharmaceuticals, supplements & cosmetics
– Import & distribution compliance under Swedish/EU law
– GDP/GMP support for Swedish wholesalers and MAH holders
– Post-approval maintenance: variations, renewals, PSUR
– Ongoing updates from Läkemedelsverket, EMA & EU Commission
🧪 Research & Development (R&D) Services – Sweden Market
💊 Formulation Development
– Tablets, capsules, syrups, liquids, powders, injectables
– EU climate stability studies (Zone II)
– Optimization for Scandinavian market requirements
🧫 Analytical R&D Services
– Assay, dissolution, impurity profiling
– Method development & validation
– Real-time & accelerated stability studies for regulatory submissions
📑 Product Development Reports (PDRs)
– PDRs in EU-CTD format
– Includes analytical results, manufacturing process & stability data
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical trial documentation per ICH-GCP (E6)
– Toxicological evaluations following OECD Guidelines
– Cosmetic safety documentation:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report
🌏 Why Choose Us for the Sweden Market
• Strong expertise in Läkemedelsverket, EMA & EU regulations
• End-to-end regulatory & technical support
• Extensive global experience across EU, US, ASEAN & ROW
• Highly compliant, fast CTD/ASMF documentation
• Tailored regulatory strategies for Nordic market requirements
📘 Regulatory & Dossier Documentation – Sweden/EU
Hashtags – Sweden & EU
#DossierSweden #DMFSweden #CTDSweden #EUCTD #ASMF
#Läkemedelsverket #RegulatorySweden #PharmaSweden
#PharmaComplianceEU #PharmaQualityEU
#StabilityStudiesEU #PSUR #BMR #MFR
#ClinicalTrialReportEU #ProcessValidationEU
⚗️ Bioequivalence & Analytical Studies – Sweden/EU
#BEStudiesEU #BioequivalenceStudyEU #AnalyticalMethodValidationEU
#AMVEU #AssayValidationEU #DissolutionValidationEU
🧪 Technology Transfer & Safety – Sweden/EU
#TechnologyTransferEU #MethodTransferEU #AnalyticalTransferEU
#MSDSEU #PharmaTechTransferEU
🌐 Top Pharma & Regulatory Hashtags – Sweden & EU
#PharmaSweden #SwedenEU #NordicPharma
#Läkemedelsverket #EUCTD #CPNP
#TechTransferEU #StabilityStudiesEU #ClinicalTrialReportEU