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

🇲🇹 Regulatory and Research Services for Malta

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

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

Our services comply with MMA, Public Health Directorate, MCCAA, EMA, EU legislation, and ICH/WHO standards.

📘 Regulatory Services for Malta

🇲🇹 Regulatory & Product Registration Support – Malta (EU)

We support companies across the entire regulatory process, ensuring compliance with:

✔ MMA – Malta Medicines Authority
✔ Superintendence of Public Health
✔ MCCAA – Cosmetics/Product Safety & Market Surveillance
✔ EMA – EU Centralized Approval
✔ EudraLex EU pharma legislation
✔ ICH Guidelines (Quality/Safety/Efficacy)

📘 Product Registration Services

• Malta/EU Dossier Preparation & Submission

– EU-CTD dossier preparation for pharmaceuticals (Rx/OTC)
– Food supplement notification as per Public Health requirements
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Regulatory support for Herbal, Ayurveda, Nutraceutical, Veterinary products
– Ingredient & claims compliance under:
✔ EU Regulation 1925/2006
✔ EU Novel Food Regulation 2015/2283
✔ EU Cosmetics Regulation 1223/2009
✔ Maltese national rules (where applicable)

• Malta/EU Label & Packaging Compliance

– Mandatory English or Maltese labeling
– Compliance with EU 1169/2011 Food Information Regulation
– Verification of allergens, warnings, nutrient claims
– Leaflet, IFU & artwork development per Malta/EU standards

📗 Drug Master File (DMF) / ASMF Services

– Preparation of EU-CTD Modules 2 & 3
– API documentation for MMA/EMA submissions
– CEP (EDQM) bridging support
– ICH Q8/Q9/Q10 technical documentation
– Support for API manufacturers entering the Maltese/EU supply chain

⚗️ Bioequivalence (BE) Study Support – EU/Malta

– BE study design according to EMA BE Guidance
– Coordination with EU-accredited CROs
– Complete BE report preparation for MMA
– BCS-based biowaiver support (Class I/III APIs)

🔬 Analytical Method Validation (AMV) Services

– Validation based on ICH Q2(R2)
– Assay, impurity, dissolution & stability validation
– Preparation of AMV protocols & final validation reports
– QC testing support for product release in Malta/EU

🧾 Regulatory Consultancy & Compliance – Malta

– Product classification (Medicine / Supplement / Cosmetic / Veterinary)
– MAH responsibilities in Malta
– GMP/GDP compliance for Maltese importers & wholesalers
– Variations, renewals, PSUR & lifecycle management
– Monitoring updates from MMA, EMA & EU Commission

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

💊 Formulation Development

– Tablets, capsules, liquids, syrups, powders, injectables
– Stability studies under EU Zone II conditions
– Formulation optimization for Maltese market requirements

🧫 Analytical R&D Services

– Method development & validation
– Assay, dissolution, impurity profiling
– Stability testing: real-time & accelerated

📑 Product Development Reports (PDRs)

– CTD-compliant PDR preparation
– Includes analytical tests, stability summaries & manufacturing details

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocols & reports per ICH-GCP (E6)
– Toxicology reporting per OECD standards
– Cosmetic compliance:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report

🌏 Why Choose Us for the Malta Market

• Expertise in MMA, Public Health, MCCAA & EMA regulatory pathways
• End-to-end documentation, regulatory & technical support
• Proven experience across EU, GCC, US, ASEAN & ROW
• High-quality & compliant CTD/DMF/ASMF preparation
• Tailored regulatory strategies for the Maltese and EU markets

📘 Regulatory & Dossier Documentation – Malta/EU

Hashtags – Malta & EU
#DossierMalta #DMFMalta #CTDMalta #MMAMalta
#RegulatoryMalta #PharmaMalta #PharmaComplianceEU
#FoodSupplementMalta #CosmeticsMalta #VeterinaryMalta
#StabilityStudiesEU #PSUR #ClinicalTrialMalta #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – EU/Malta

#BEStudiesEU #BioequivalenceEU #AMVEU
#DissolutionValidationEU #AssayValidationEU

🧪 Technology Transfer & Safety – EU/Malta

#TechnologyTransferEU #PharmaTechTransferEU
#AnalyticalTransferEU #MethodTransferEU #MSDSEU

🌐 Top Pharma & Regulatory Hashtags – Malta

#PharmaMalta #MaltaRegulatory #EUCTD #MMAMalta #EMA
#ClinicalTrialEU #StabilityStudiesMalta #TechTransferEU