Regulatory And Research Services for Regulatory-Services-Coverage-by-Germany-Market
🇩🇪 Regulatory and Research Services for Germany
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, provide comprehensive regulatory and research services for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the German (EU) market.
Our services ensure compliance with BfArM, PEI, BVL, EMA, EU regulations, and international ICH/WHO standards.
📘 Regulatory Services for Germany
🇩🇪 Regulatory & Product Registration Support – Germany (EU)
We support companies through the complete regulatory & approval pathway for entering the German and EU market, ensuring adherence to:
✔ BfArM – Federal Institute for Drugs & Medical Devices
✔ PEI – Paul-Ehrlich-Institut (Vaccines & Biologicals)
✔ BVL – German Federal Office for Consumer Protection & Food Safety (Supplements)
✔ EMA – European Medicines Agency
✔ EU EudraLex Pharmaceutical Legislation
✔ ICH Q/S/E Guidelines
📘 Product Registration Services
• Germany/EU Dossier Preparation & Product Approvals
– EU-CTD dossier preparation for pharmaceuticals (Rx/OTC)
– Food supplement notification to BVL (Vitamins, botanicals, minerals)
– Cosmetic product notification through CPNP (EU Cosmetic Portal)
– Regulatory support for Herbal, Ayurveda, Nutraceutical, Veterinary products
– Ingredient & claims verification based on:
✔ EU Regulation (EC) 1925/2006 – Nutrition/Health Claims
✔ EU Regulation (EU) 2015/2283 – Novel Foods
✔ EU Cosmetics Regulation (EC) 1223/2009
✔ German national safety lists (e.g., BELFRIT/plant lists)
• Germany/EU Label & Packaging Compliance
– Mandatory German-language label review
– Compliance with EU 1169/2011 Food Information Regulation
– Allergen, warning & permitted claims verification
– Artwork, IFU & product leaflet preparation per German/EU regulations
📗 Drug Master File (DMF) / ASMF Services
– Preparation of EU-CTD Modules 2 & 3 for ASMF/DMF
– API documentation aligned with BfArM/PEI/EMA requirements
– CEP (EDQM) support & bridging for German submissions
– ICH Q8/Q9/Q10 based technical documentation
– Support for API manufacturers entering the German/EU marketplace
⚗️ Bioequivalence (BE) Study Support – EU/Germany
– BE protocol design based on EMA BE Guidelines
– Coordination with EU/EEA-certified CROs
– BE report preparation for BfArM/PEI/EMA
– Biowaiver justification using BCS classification & EMA principles
🔬 Analytical Method Validation (AMV) Services
– Validation per ICH Q2(R2)
– Assay, dissolution, impurity, stability method development
– AMV protocol + full validation report preparation
– QC support for German importers & EU manufacturer compliance
🧾 Regulatory Consultancy & Compliance – Germany
– Product classification (medicine / supplement / cosmetic / veterinary)
– MAH (Marketing Authorization Holder) & German importer guidance
– GDP/GMP compliance preparation for German distributors
– Variations, renewals, PSUR submission handling
– Continuous monitoring of BfArM + EMA + EU Commission updates
🧪 Research & Development (R&D) Services – German Market
💊 Formulation Development
– Tablets, capsules, syrups, liquids, powders, injectables
– EU Zone II stability studies per German climate conditions
– Product optimization for German market expectations & EU standards
🧫 Analytical R&D Services
– Method development, assay, impurity profiling, dissolution tests
– Stability studies (real-time & accelerated)
– Full documentation for German/EU submissions
📑 Product Development Reports (PDRs)
– EU-CTD format PDR preparation
– Includes analytical results, process development & stability profiles
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical documentation (protocols, CSR) per ICH-GCP (E6)
– Toxicology studies as per OECD standards
– Cosmetic compliance:
✔ CPSR – Cosmetic Product Safety Report
✔ PIF – Product Information File
🌏 Why Choose Us for the Germany Market
• Experts in BfArM, PEI, BVL, EMA & EU regulatory frameworks
• End-to-end regulatory, technical & documentation support
• Global experience: EU, US, GCC, ASEAN, ROW
• Fast & compliant CTD/ASMF preparation
• Market-specific strategies tailored for the German pharma & supplement industry
📘 Regulatory & Dossier Documentation – Germany/EU
Hashtags – Germany & EU
#DossierGermany #DMFGermany #CTDGermany
#BfArM #PEI #BVL #RegulatoryGermany
#PharmaGermany #PharmaComplianceEU
#FoodSupplementGermany #CosmeticsGermany #VeterinaryGermany
#StabilityStudiesEU #PSUR #ClinicalTrialGermany #MFR #BMR
⚗️ Bioequivalence & Analytical Studies – EU/Germany
#BEStudiesEU #BioequivalenceEU #AMVEU
#AssayValidationEU #DissolutionValidationEU
🧪 Technology Transfer & Safety – EU/Germany
#TechnologyTransferEU #PharmaTechTransferEU
#AnalyticalTransferEU #MethodTransferEU #MSDSEU
🌐 Top Pharma & Regulatory Hashtags – Germany
#PharmaGermany #GermanyRegulatory #EUCTD #EMA #BfArM
#ClinicalTrialEU #TechTransferEU #StabilityStudiesGermany