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

🇫🇷 Regulatory and Research Services for France

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

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

All services comply with ANSM, DGCCRF, EMA, EU regulations, and international ICH/WHO standards.

📘 Regulatory Services for France

🇫🇷 Regulatory & Product Registration Support – France (EU)

We support companies throughout the full regulatory submission and approval process for entering France and the broader European Union, ensuring compliance with:

✔ ANSM – French Medicines Agency
✔ DGCCRF – Directorate-General for Competition, Consumer Affairs & Fraud Control
✔ Ministry of Health (Ministère des Solidarités et de la Santé)
✔ EMA – European Medicines Agency
✔ EU EudraLex Framework
✔ ICH Q/S/E Guidelines

📘 Product Registration Services

• France/EU Dossier Preparation & Product Approvals

– Preparation of EU-CTD dossiers for pharmaceuticals (Rx/OTC)
– Food supplement notification to DGCCRF (via TéléIcare portal)
– Cosmetic product notification through CPNP (EU Cosmetic Portal)
– Registration support for Herbal, Ayurveda, Nutraceutical & Veterinary products
– Ingredient & claims validation as per:
✔ EU Regulation (EC) 1925/2006
✔ EU Regulation (EU) 2015/2283 (Novel Foods)
✔ EU Cosmetics Regulation (EC) 1223/2009
✔ French national requirements (e.g., plant lists, permitted health claims)

• France/EU Label & Packaging Compliance

– Mandatory French-language label review
– Compliance with EU 1169/2011 Food Information Regulation
– Verification of allergen declarations, warnings, nutrition claims
– Artwork, IFU, and packaging development per French/EU standards

📗 Drug Master File (DMF) / ASMF Services

– Preparation of EU-CTD Module 2 & 3 for ASMF/DMF
– API documentation compliant with ANSM & EMA
– CEP (EDQM) bridging support for France
– ICH Q8/Q9/Q10 compliant technical dossiers
– Full support for manufacturers supplying APIs to the French/EU market

⚗️ Bioequivalence (BE) Study Support – EU/France

– BE protocol development as per EMA guidelines
– Coordination with EU-accredited CROs
– Preparation of BE study reports for ANSM/EMA
– Biowaiver justification (BCS Class I/III)

🔬 Analytical Method Validation (AMV) Services

– ICH Q2(R2)-compliant analytical method validation
– Assay, dissolution, impurity method development
– AMV protocols, data sheets & validation reports
– QC technical support for France & EU submissions

🧾 Regulatory Consultancy & Compliance – France

– Product classification support (medicine / supplement / cosmetic / veterinary)
– French-specific botanical safety & permitted claim checks
– GMP/GDP compliance guidance for French importers & distributors
– Variations, renewals, PSUR, RMP & lifecycle management
– Monitoring of ANSM + DGCCRF + EMA regulatory updates

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

💊 Formulation Development

– Tablets, capsules, syrups, powders, liquids, injectables
– EU Zone II stability studies for French market
– Optimization for French climatic & consumer requirements

🧫 Analytical R&D Services

– Assay, impurity, dissolution profiling
– Method development & validation
– Real-time & accelerated stability studies (EU-compliant)

📑 Product Development Reports (PDRs)

– PDRs in EU-CTD format
– Includes formulation, manufacturing controls, & stability data

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocols & reports as per ICH-GCP E6
– Toxicology studies following OECD guidelines
– Cosmetic compliance:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report

🌏 Why Choose Us for the France Market

• Experts in ANSM, DGCCRF, EMA, EU regulatory systems
• End-to-end product registration & technical documentation support
• Strong experience across EU, US, GCC, ASEAN & ROW
• Fast and compliant CTD/ASMF dossier preparation
• Product-specific regulatory strategies tailored for France

📘 Regulatory & Dossier Documentation – France/EU

Hashtags – France & EU
#DossierFrance #DMFFrance #CTDFrance #ANSM #DGCCRF
#RegulatoryFrance #PharmaFrance #PharmaComplianceEU
#FoodSupplementFrance #CosmeticsFrance #VeterinaryFrance
#StabilityStudiesEU #PSUR #ClinicalTrialFrance #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – EU/France

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

🧪 Technology Transfer & Safety – EU/France

#TechnologyTransferEU #MethodTransferEU #AnalyticalTransferEU
#MSDSEU #PharmaTechTransferEU

🌐 Top Pharma & Regulatory Hashtags – France

#PharmaFrance #FranceRegulatory #EUCTD #ANSMFrance #EMA
#PharmaQualityEU #TechTransferEU #ClinicalTrialEU
#StabilityStudiesFrance