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

🇧🇪 Regulatory and Research Services for Belgium

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

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

Our services fully comply with FAMHP, FPS Public Health, EMA, EU Directives, and ICH/WHO guidelines.

📘 Regulatory Services for Belgium

🇧🇪 Regulatory & Product Registration Support – Belgium (EU)

We support companies throughout the registration and compliance process for the Belgium market, ensuring alignment with:

✔ FAMHP – Federal Agency for Medicines and Health Products
✔ FPS Health, Food Chain Safety and Environment
✔ EMA – European Medicines Agency
✔ EU EudraLex Pharmaceutical Legislation
✔ ICH Q/S/E Guidelines

📘 Product Registration Services

• Belgium/EU Dossier Preparation & Product Approvals

– EU-CTD dossier preparation for pharmaceuticals (Rx/OTC)
– Food supplement notification to FPS Public Health (Vitamins, Minerals, Botanicals)
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Support for Herbal, Ayurveda, Nutraceutical, Veterinary product registration
– Ingredient compliance & claims validation based on:
✔ EU Regulation (EC) 1925/2006
✔ EU Novel Food Regulation (EU 2015/2283)
✔ EU Cosmetics Regulation (EC) 1223/2009

• Belgium/EU Label & Packaging Compliance

– French / Dutch / German labeling (Belgium’s 3 official languages depending on region)
– Compliance with EU Regulation 1169/2011 (Food Information Regulation)
– Verification of warnings, allergens, nutritional claims
– Artwork, IFU, and packaging development as per Belgian/EU regulations

📗 Drug Master File (DMF) / ASMF Services

– Preparation of EU-CTD Modules 2 & 3
– API documentation compliant with FAMHP & EMA
– CEP (EDQM) bridging/reference support
– ICH Q8, Q9 & Q10-based technical documentation
– Support for manufacturers supplying Belgian/EU pharmaceutical markets

⚗️ Bioequivalence (BE) Study Support – EU/Belgium

– Protocol and BE study design per EMA BE Guidelines
– Coordination with EU-certified CROs
– Preparation of complete BE reports for FAMHP/EMA
– Biowaiver (BCS-based) justification support

🔬 Analytical Method Validation (AMV) Services

– Method validation per ICH Q2(R2)
– Assay, dissolution, impurity profiling, stability validation
– AMV protocol + final validation report development
– QC support for manufacturers and Belgian/EU importers

🧾 Regulatory Consultancy & Compliance – Belgium

– Product classification: medicine / supplement / cosmetic / veterinary
– MAH (Marketing Authorization Holder) guidance for Belgium
– GMP/GDP compliance for Belgian pharmaceutical distributors
– Managing variations, renewals, PSUR submissions
– Continuous updates on FAMHP, EMA, EU Commission notifications

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

💊 Formulation Development

– Tablets, capsules, syrups, powders, liquids, injectables
– EU Zone II stability testing
– Optimization for EU regulatory and climatic conditions

🧫 Analytical R&D Services

– Method development & validation
– Impurity profiling, dissolution studies
– Real-time and accelerated stability studies

📑 Product Development Reports (PDRs)

– EU-CTD compliant PDR preparation
– Includes development summary, analytical results, & stability profiles

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documents following ICH-GCP E6(R2)
– Toxicology assessments per OECD Standards
– Cosmetic safety:
✔ CPSR (Cosmetic Product Safety Report)
✔ PIF (Product Information File)

🌏 Why Choose Us for the Belgium Market

• Expertise in FAMHP, FPS, EMA, EU regulatory frameworks
• End-to-end regulatory + technical documentation support
• Global experience across EU, US, ASEAN, GCC, ROW
• Fast, compliant CTD/ASMF/DMF submissions
• Market-specific regulatory strategies tailored for Belgium

📘 Regulatory & Dossier Documentation – Belgium/EU

Hashtags – Belgium & EU
#DossierBelgium #DMFBelgium #CTDBelgium #FAMHP
#RegulatoryBelgium #PharmaBelgium #PharmaComplianceEU
#FoodSupplementBelgium #CosmeticsBelgium #VeterinaryBelgium
#StabilityStudiesEU #PSUR #ClinicalTrialBelgium #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – EU/Belgium

#BEStudiesEU #BioequivalenceEU #AnalyticalMethodValidationEU
#AMVEU #AssayValidationEU #DissolutionValidationEU

🧪 Technology Transfer & Safety – EU/Belgium

#TechnologyTransferEU #PharmaTechTransferEU
#AnalyticalTransferEU #MethodTransferEU #MSDSEU

🌐 Top Pharma & Regulatory Hashtags – Belgium & EU

#PharmaBelgium #BelgiumRegulatory #EUCTD #FAMHP #EMA
#PharmaQualityEU #TechTransferEU #ClinicalTrialEU
#StabilityStudiesBelgium