Regulatory And Research Services for Regulatory-Services-Coverage-by-Austria-Market
🇦🇹 Regulatory and Research Services for Austria
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, provide complete regulatory and research solutions for pharmaceutical, nutraceutical, herbal, food supplement, veterinary, and cosmetic companies aiming to enter the Austrian (EU) market.
Our services are fully compliant with BASG/AGES, EMA, EU Directives, Austrian national requirements, and ICH/WHO standards.
📘 Regulatory Services for Austria
🇦🇹 Regulatory & Product Registration Support – Austria (EU)
We support companies at every stage of regulatory submission and market entry, ensuring compliance with:
✔ BASG/AGES – Austrian Medicines & Medical Devices Agency
✔ BMSGPK – Federal Ministry of Social Affairs, Health, Care and Consumer Protection
✔ EMA – European Medicines Agency
✔ EudraLex EU pharma regulations
✔ ICH Standards (Quality/Safety/Efficacy)
📘 Product Registration Services
• Austria/EU Dossier Preparation & Submission
– EU-CTD dossier preparation for pharmaceuticals (Rx/OTC)
– Food supplement notification to AGES
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Regulatory support for Herbal, Ayurveda, Nutraceutical, Veterinary products
– Ingredient & claims compliance based on:
✔ EU Regulation (EC) 1925/2006 – Health & Nutrition Claims
✔ EU Regulation (EU) 2015/2283 – Novel Foods
✔ EU Cosmetics Regulation (EC) 1223/2009
• Austria/EU Label & Packaging Compliance
– Mandatory German-language label review
– Compliance with EU 1169/2011 Food Information Regulation
– Verification of allergens, nutrition claims, warnings
– Packaging, IFU, leaflets & artwork per Austria/EU requirements
📗 Drug Master File (DMF) / ASMF Services
– Compilation of EU-CTD Modules 2 & 3 for ASMF/DMF submission
– API quality documentation compliant with BASG/EMA
– CEP (EDQM) preparation & bridging for Austria
– ICH Q8/Q9/Q10 compliant technical documentation
– Support for manufacturers entering Austria/EU pharmaceutical supply chain
⚗️ Bioequivalence (BE) Study Support – EU/Austria
– BE study design & interpretation as per EMA Guidelines
– Coordination with EU/EEA-certified CROs
– BE report preparation for BASG/EMA
– Biowaiver justification (BCS Class I/III)
🔬 Analytical Method Validation (AMV) Services
– Validation according to ICH Q2(R2)
– Assay, impurity, dissolution, RS & stability studies
– AMV protocol, raw data, validation report creation
– QC support for Austria-compliant product release
🧾 Regulatory Consultancy & Compliance – Austria
– Classification support (pharma / supplement / cosmetic / veterinary)
– MAH (Marketing Authorization Holder) requirements
– GMP/GDP compliance for Austrian distributors
– Post-approval maintenance: variations, renewals, PSUR
– Continuous monitoring of BASG + EMA + EU regulatory changes
🧪 Research & Development (R&D) Services – Austrian Market
💊 Formulation Development
– Tablets, capsules, syrups, powders, injectables
– Stability testing aligned with EU Zone II conditions
– Formulation optimization for Austria’s climate & EU regulations
🧫 Analytical R&D Services
– Assay, dissolution, impurity profiling
– Method development & validation
– Real-time & accelerated stability studies
📑 Product Development Reports (PDRs)
– EU-CTD style PDR documentation
– Includes manufacturing process, analytical results & stability data
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical trial documents (protocols, CTRs, CSR) as per ICH-GCP (E6)
– Toxicology studies following OECD guidelines
– Cosmetic safety compliance documentation:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report
🌏 Why Choose Us for the Austria Market
• Experts in BASG/AGES, EMA, and EU regulatory frameworks
• End-to-end regulatory & technical dossier preparation
• Global experience in EU, US, ASEAN, GCC & ROW
• Fast, highly compliant CTD/ASMF submission
• Tailored regulatory strategy for Austrian/EU-specific requirements
📘 Regulatory & Dossier Documentation – Austria/EU
Hashtags – Austria & EU
#DossierAustria #DMFAustria #CTDAustria #BASG #AGES
#RegulatoryAustria #PharmaAustria #PharmaComplianceEU
#FoodSupplementAustria #CosmeticsAustria #VeterinaryAustria
#StabilityStudiesEU #PSUR #ClinicalTrialAustria #BMR #MFR
⚗️ Bioequivalence & Analytical Studies – Austria/EU
#BEStudiesEU #BioequivalenceStudyEU #AnalyticalMethodValidationEU
#AMVEU #DissolutionValidationEU #AssayValidationEU
🧪 Technology Transfer & Safety – Austria/EU
#TechnologyTransferEU #MethodTransferEU #AnalyticalTransferEU
#MSDSEU #PharmaTechTransferEU
🌐 Top Pharma & Regulatory Hashtags – Austria & EU
#PharmaAustria #AustriaRegulatory #EUCTD #BASG #EMA
#PharmaManufacturingEU #TechTransferEU #ClinicalTrialAustria
#StabilityStudiesAustria