Regulatory And Research Services for Regulatory-Services-Coverage-by-Norway-Market
🇳🇴 Regulatory and Research Services for Norway
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, deliver end-to-end regulatory and research services for pharmaceutical, nutraceutical, herbal, food supplement, veterinary, and cosmetic companies targeting the Norwegian (EEA) market.
Our services ensure compliance with NoMA, Mattilsynet, EMA (EEA alignment), EU Directives, and ICH/WHO guidelines.
📘 Regulatory Services for Norway
🇳🇴 Regulatory & Product Registration Support – Norway (EEA)
We assist companies across the full regulatory pathway for entering Norway, ensuring alignment with:
✔ NoMA (Legemiddelverket – Norwegian Medicines Agency)
✔ Mattilsynet (Norwegian Food Safety Authority)
✔ EMA (European Medicines Agency) – via EEA compliance
✔ EU/EEA Regulatory Framework
✔ ICH Q/S/E guidelines
📘 Product Registration Services
• Norway/EEA Dossier Preparation & Registration
– EU-CTD dossier preparation for pharmaceutical products (Rx/OTC)
– Food supplement notification to Mattilsynet
– Cosmetic notification via CPNP (as Norway follows EU Cosmetics Regulation)
– Regulatory support for Herbal, Ayurveda, Nutraceutical, Veterinary products
– Ingredient/claim compliance based on:
✔ (EC) 1925/2006 – Nutrition & Health Claims
✔ (EC) 2015/2283 – Novel Food
✔ (EC) 1223/2009 – Cosmetics Regulation (fully applicable in Norway)
• Norway Label & Packaging Compliance
– Norwegian-language labeling (mandatory)
– Compliance with EU Regulation 1169/2011 (adopted by EEA)
– Allergen, warning, health claim compliance
– Multilingual packaging support & IFU/leaflet development
📗 Drug Master File (DMF) / ASMF Services
– Preparation of EU-CTD Modules 2 & 3 for ASMF/DMF
– API documentation compliant with NoMA & EMA
– CEP (EDQM) support for API registration
– ICH Q8–Q10 compliant technical documentation
– Support for API suppliers entering the Norwegian/EU/EEA markets
⚗️ Bioequivalence (BE) Study Support – EEA/Norway
– BE study design based on EMA BE Guidelines
– Coordination with EEA-accredited CROs
– BE study report preparation for NoMA and EMA
– Biowaiver justification support (BCS-based)
🔬 Analytical Method Validation (AMV) Services
– Validation as per ICH Q2(R2)
– Method development for assay, dissolution, impurities, stability
– Preparation of AMV protocol, raw data, and validation report
– Support for QC laboratories and product release testing
🧾 Regulatory Consultancy & Compliance – Norway
– Product classification guidance (pharmaceutical, supplement, cosmetic)
– Importer/Marketing Authorization Holder (MAH) compliance for Norway
– GDP/GMP support for Norwegian wholesalers & distributors
– Lifecycle management: variations, renewals, PSUR, signal updates
– Monitoring of regulatory updates from NoMA, EMA, and EEA
🧪 Research & Development (R&D) Services – Norway Market
💊 Formulation Development
– Tablets, capsules, syrups, liquids, powders, injectables
– Stability studies under EU/EEA climate conditions
– Bioavailability optimization & formulation improvement
🧫 Analytical R&D Services
– Assay, dissolution, impurity profiling
– QC method development & validation
– Stability (real-time & accelerated) for EEA submissions
📑 Product Development Reports (PDRs)
– EU-CTD format PDRs
– Manufacturing process development, analytical data & stability summary
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical trial protocols & reports per ICH-GCP E6
– Toxicology evaluations as per OECD standards
– Cosmetic safety documentation:
✔ PIF (Product Information File)
✔ CPSR (Cosmetic Product Safety Report)
🌏 Why Choose Us for the Norway Market
• Specialists in NoMA, EMA, EU/EEA compliance frameworks
• End-to-end regulatory support: development → dossier → approval → compliance
• Strong experience across EU, Nordic, US, ASEAN, and ROW markets
• Fast documentation turnaround (CTD/ASMF/CEP)
• Market-specific, Norway-focused regulatory strategies
📘 Regulatory & Dossier Documentation – Norway/EEA
Hashtags – Norway & EEA
#DossierNorway #DMFNorway #CTDNorway #EUCTD #ASMF
#NoMA #Legemiddelverket #RegulatoryNorway #PharmaNorway
#PharmaComplianceEEA #PharmaQualityEU #PSUR #StabilityStudiesEU
#ClinicalTrialReportEU #BMR #MFR #PharmaValidationEU
⚗️ Bioequivalence & Analytical Studies – Norway/EEA
#BEStudiesEU #BioequivalenceStudyEU #AnalyticalMethodValidationEU
#AMVEU #DissolutionValidationEU #AssayValidationEU
🧪 Technology Transfer & Safety – Norway/EEA
#TechnologyTransferEU #AnalyticalTransferEU #MethodTransferEU
#MSDSEU #PharmaTechTransferEU
🌐 Top Pharma & Regulatory Hashtags – Norway & EEA
#PharmaNorway #NorwayEEA #NoMA #EUCTD #CPNP
#PharmaManufacturingEU #PharmaQualityEU #TechTransferEU
#StabilityStudiesEU #ClinicalTrialReportEU