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

🇳🇱 Regulatory and Research Services for the Netherlands

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, provide complete regulatory and research services for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Netherlands (EU) market.

Our services ensure full compliance with CBG–MEB, IGJ, NVWA, EMA, EU Regulations, and ICH/WHO guidelines.

📘 Regulatory Services for the Netherlands

🇳🇱 Regulatory & Product Registration Support – Netherlands (EU)

We support companies through the entire regulatory process for entering the Dutch market, aligned with:

✔ CBG–MEB – Medicines Evaluation Board (Medicines & Biologicals)
✔ IGJ – Health and Youth Care Inspectorate (GMP/GDP compliance)
✔ NVWA – Netherlands Food & Consumer Product Safety Authority (Supplements, Cosmetics)
✔ EMA – EU Centralized approval
✔ EU EudraLex
✔ ICH Q/S/E Guidelines

📘 Product Registration Services

• Netherlands/EU Dossier Preparation & Submission

– EU-CTD dossier preparation for pharmaceuticals (Rx/OTC)
– Food supplement compliance & notification to NVWA
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Support for Herbal, Ayurveda, Nutraceutical, Veterinary product registration
– Ingredient, label & health claim verification under:
✔ EU Regulation 1925/2006
✔ EU Novel Food Regulation 2015/2283
✔ EU Cosmetics Regulation 1223/2009
✔ Dutch botanical safety lists

• Netherlands/EU Label & Packaging Compliance

– Mandatory Dutch-language labeling
– Compliance with EU 1169/2011 Food Information Regulation
– Verification of allergens, warnings, nutrition & health claims
– Artwork development (NL/EU packaging & leaflets)

📗 Drug Master File (DMF) / ASMF Services

– Preparation of EU-CTD Module 2 & 3 for ASMF/DMF
– API documentation for CBG–MEB/EMA
– CEP (EDQM) bridging support
– ICH Q8–Q10 compliant technical documentation
– Support for API suppliers entering Dutch/EU pharma supply chains

⚗️ Bioequivalence (BE) Study Support – EU/Netherlands

– BE study design aligned with EMA BE Guidelines
– Coordination with EU-accredited CROs
– Preparation of BE study reports for CBG–MEB submissions
– Biowaiver (BCS-based) justification support

🔬 Analytical Method Validation (AMV) Services

– Method validation as per ICH Q2(R2)
– Assay, impurity, dissolution & stability method development
– AMV protocols, raw data & validation report preparation
– QC method transfer support for EU/NL manufacturers

🧾 Regulatory Consultancy & Compliance – Netherlands

– Product classification (medicine / supplement / cosmetic / veterinary)
– MAH (Marketing Authorization Holder) regulatory guidance
– GMP/GDP compliance support (IGJ requirements)
– Variations, renewals, PSUR & post-approval lifecycle management
– Ongoing monitoring of CBG–MEB, NVWA & EMA regulatory updates

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

💊 Formulation Development

– Tablets, capsules, syrups, liquids, powders, injectables
– Stability studies as per EU Zone II
– Formulation optimization for Dutch/EU markets

🧫 Analytical R&D Services

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

📑 Product Development Reports (PDRs)

– Full PDRs in EU-CTD format
– Includes analytical results, manufacturing controls & stability summary

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocols & reports per ICH-GCP (E6)
– Toxicology reporting under OECD guidelines
– Cosmetic compliance:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report

🌏 Why Choose Us for the Netherlands Market

• Experts in CBG–MEB, NVWA, EMA & EU regulatory frameworks
• End-to-end regulatory, technical & documentation support
• Proven experience across EU, US, GCC, ASEAN & ROW
• Fast & compliant CTD/ASMF dossier preparation
• Tailored strategies for pharmaceuticals, supplements & cosmetics in the Dutch market

📘 Regulatory & Dossier Documentation – Netherlands/EU

Hashtags – Netherlands & EU
#DossierNetherlands #DMFNetherlands #CTDNetherlands #CBGMEB
#RegulatoryNetherlands #PharmaNetherlands
#NVWANetherlands #CosmeticsNetherlands #FoodSupplementNetherlands
#PharmaComplianceEU #StabilityStudiesEU #PSUR #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Netherlands/EU

#BEStudiesEU #BioequivalenceEU #AMVEU
#DissolutionValidationEU #AssayValidationEU

🧪 Technology Transfer & Safety – Netherlands/EU

#TechnologyTransferEU #MethodTransferEU #AnalyticalTransferEU
#MSDSEU #PharmaTechTransferEU

🌐 Top Pharma & Regulatory Hashtags – Netherlands

#PharmaNL #NetherlandsRegulation #CBGMEB #NVWA #EMA
#EUCTD #PharmaQualityEU #ClinicalTrialEU #TechTransferEU