Regulatory And Research Services for Regulatory-Services-Coverage-by-Denmark-Market
🇩🇰 Regulatory and Research Services for Denmark
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, offer comprehensive regulatory and research support to pharmaceutical, nutraceutical, herbal, food supplement, and cosmetic companies seeking entry into the Danish (EU) market.
Our services ensure compliance with DKMA, EMA, EU Regulations, and ICH/WHO guidelines.
📘 Regulatory Services for Denmark
🇩🇰 Regulatory & Product Registration Support – Denmark (EU)
We support companies during every stage of regulatory submission and product approval for the Denmark and broader EU market, ensuring alignment with:
✔ DKMA (Danish Medicines Agency)
✔ EMA
✔ EU Regulations & Directives
✔ ICH Quality, Safety & Efficacy guidelines
📘 Product Registration Services
• EU/Denmark Dossier Preparation & Registration
– Preparation of EU-CTD dossiers for pharmaceuticals (Rx/OTC)
– Food supplement notification to the Danish Veterinary and Food Administration (DVFA / Fødevarestyrelsen)
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Herbal, Ayurveda, Nutraceutical, Veterinary product compliance review
– Ingredient & claim checks under:
✔ Regulation (EC) 1223/2009 – Cosmetics
✔ Regulation (EC) 2015/2283 – Novel Foods
✔ Regulation (EC) 1925/2006 – Food Additives/Health Claims
• Denmark/EU Label & Packaging Compliance
– Danish-language label review (mandatory for DK market)
– Compliance with EU 1169/2011 Food Information Regulation
– Verification of claims, allergens, warnings, and mandatory statements
– IFU/leaflet and multi-language artwork support
📗 Drug Master File (DMF) / ASMF Services
– Preparation of EU-CTD Modules 2 & 3 for ASMF/DMF
– API regulatory documentation compliant with DKMA & EMA
– CEP (EDQM) support for API manufacturers
– Complete technical documentation following ICH Q8–Q10 and EU-GMP Part II
⚗️ Bioequivalence (BE) Study Support – EU/Denmark
– Design of BE studies as per EMA BE Guidelines
– Coordination with authorized CROs in the EU/EEA
– Preparation of BE study reports for submission to DKMA/EMA
🔬 Analytical Method Validation (AMV) Services
– ICH Q2(R2)-compliant method validation
– Method development, optimization, and documentation
– Dissolution, assay, impurity, stability method validation
🧾 Regulatory Consultancy & Compliance
– Strategy for import, distribution, and market entry in Denmark
– GMP/GDP compliance support for Danish wholesalers/importers
– Handling variations, renewals, PSUR, and lifecycle management
– Monitoring DKMA, EMA, and EU regulatory updates for continuous compliance
🧪 Research & Development (R&D) Services – Denmark Market
💊 Formulation Development
– Tablets, capsules, liquids, powders, injectables
– Stability testing for EU climate conditions
– Bioavailability enhancements & performance optimization
🧫 Analytical R&D Services
– Assay, dissolution, impurity studies
– Method development for routine QC & regulatory use
– Real-time & accelerated stability testing
📑 Product Development Reports (PDRs)
– EU-CTD format PDR documentation
– Detailed manufacturing, analytical, and stability records
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical trial protocol development & report writing (ICH-GCP E6)
– Toxicology reporting per OECD standards
– EU cosmetic compliance: PIF compilation, CPSR safety assessment, and toxicological review
🌏 Why Choose Us for the Denmark Market
• Experts in DKMA, EMA, and EU regulatory frameworks
• End-to-end technical and regulatory service delivery
• Proven global experience across EU, US, ASEAN, and ROW
• Fast turnaround with highly compliant documentation
• Tailored regulatory strategies for your specific product category
📘 Regulatory & Dossier Documentation – Denmark/EU
Hashtags – Denmark & EU
#DossierDenmark #DMFDenmark #CTDDenmark #EUCTD #ASMF #DKMA
#RegulatoryDenmark #PharmaDenmark #RegulatoryEU #PharmaDossierEU
#PharmaComplianceDenmark #PharmaQualityEU #StabilityStudiesEU
#PSUR #CTReportEU #ToxicityReportEU #ProcessValidationEU #BMR #MFR
⚗️ Bioequivalence & Analytical Studies – Denmark/EU
#BEStudiesEU #BioequivalenceStudyEU #AnalyticalMethodValidationEU
#AMVEU #DissolutionValidationEU #AssayValidationEU
🧪 Technology Transfer & Safety – Denmark/EU
#TechnologyTransferEU #PharmaTechTransferEU #MethodTransferEU
#AnalyticalTransferEU #MSDSEU
🌐 Top Pharma & Regulatory Hashtags – Denmark & EU
#PharmaDenmark #DanishPharma #RegulatoryEU #DKMA #EUCTD #CPNP
#PharmaManufacturingEU #PharmaQualityEU #PharmaValidationEU
#StabilityStudiesEU #ClinicalTrialReportEU #TechTransferEU