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

🇵🇹 Regulatory and Research Services for Portugal

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, offer comprehensive regulatory and research services for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies targeting the Portuguese (EU) market.

Our services comply with INFARMED, DGS, DGAV, EMA, and EU/ICH/WHO regulations.

📘 Regulatory Services for Portugal

🇵🇹 Regulatory & Product Registration Support – Portugal (EU)

We support companies entering Portugal’s market through full compliance with:

✔ INFARMED – National Authority of Medicines & Health Products
✔ DGS – Directorate-General of Health
✔ DGAV – Veterinary Products Authority
✔ EMA – European Medicines Agency
✔ EU EudraLex legislation
✔ ICH Q/S/E Guidelines

📘 Product Registration Services

• Portugal/EU Dossier Preparation & Submission

– EU-CTD dossier preparation for pharmaceuticals (Rx/OTC)
– Food supplement notification to DGS
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Registration support for Herbal, Ayurveda, Nutraceutical & Veterinary products
– Ingredient & claims compliance verification under:
✔ EU Health & Nutrition Claims Regulation (1925/2006)
✔ EU Novel Food Regulation (2015/2283)
✔ EU Cosmetics Regulation (1223/2009)
✔ Portuguese botanical monographs / safety lists

• Portugal/EU Label & Packaging Compliance

– Mandatory Portuguese-language labeling
– Compliance with EU 1169/2011 Food Information Regulation
– Validation of warnings, allergens, permitted health claims
– Packaging, leaflets, IFU & artwork development for Portugal/EU market

📗 Drug Master File (DMF) / ASMF Services

– Preparation of ASMF/DMF (EU-CTD Module 2 & 3)
– API documentation for INFARMED/EMA
– CEP (EDQM) bridging for Portuguese submissions
– ICH Q8–Q10-compliant quality documentation
– Support for API manufacturers exporting to Portugal/EU

⚗️ Bioequivalence (BE) Study Support – EU/Portugal

– BE study design per EMA BE Guideline
– Coordination with EU-certified CROs
– BE study report preparation for INFARMED
– Biowaiver (BCS-based) justification support

🔬 Analytical Method Validation (AMV) Services

– Validation following ICH Q2(R2)
– Method development & validation (assay, impurities, dissolution, stability)
– AMV protocol + full validation report
– QC support for product release in Portugal/EU

🧾 Regulatory Consultancy & Compliance – Portugal

– Product classification (medicine / supplement / cosmetic / veterinary)
– MAH (Marketing Authorization Holder) support
– Importer, distributor, and RP obligations for Portugal
– GMP/GDP guidance for Portuguese wholesalers
– Variations, renewals, PSUR & lifecycle management
– Continuous monitoring of INFARMED + EU + DGS updates

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

💊 Formulation Development

– Tablets, capsules, liquids, powders, syrups, injectables
– Stability studies aligned with EU Zone II
– Formulation optimization for Portuguese regulatory + climatic conditions

🧫 Analytical R&D Services

– Method development & validation
– Assay, impurity profiling, dissolution
– Stability: real-time and accelerated per EU standards

📑 Product Development Reports (PDRs)

– Preparation of PDR in EU-CTD format
– Includes development process, analytical results & stability summaries

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documentation aligned with ICH-GCP (E6)
– Submission support for INFARMED clinical trials
– Toxicology evaluation per OECD guidelines
– Cosmetic compliance documentation:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report

🌏 Why Choose Us for the Portugal Market

• Experts in INFARMED, DGS, DGAV, EMA regulatory processes
• End-to-end regulatory documentation & submission management
• Extensive global experience: EU, US, GCC, ASEAN, ROW
• Fast & compliant CTD/DMF/ASMF preparation
• Tailored regulatory strategies for Portugal/EU markets

📘 Regulatory & Dossier Documentation – Portugal/EU

Hashtags – Portugal & EU
#DossierPortugal #DMFPortugal #CTDPortugal #INFARMED
#RegulatoryPortugal #PharmaPortugal #PharmaComplianceEU
#FoodSupplementPortugal #CosmeticsPortugal #VeterinaryPortugal
#StabilityStudiesEU #PSUR #ClinicalTrialPortugal #MFR #BMR

⚗️ Bioequivalence & Analytical Studies – Portugal/EU

#BEStudiesEU #BioequivalenceEU #AMVEU
#AssayValidationEU #DissolutionValidationEU

🧪 Technology Transfer & Safety – Portugal/EU

#TechnologyTransferEU #PharmaTechTransferEU
#MethodTransferEU #AnalyticalTransferEU #MSDSEU

🌐 Top Pharma & Regulatory Hashtags – Portugal

#PharmaPortugal #PortugalRegulatory #EUCTD #EMA #INFARMED
#ClinicalTrialEU #StabilityStudiesPortugal #TechTransferEU