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

🇱🇻 Regulatory and Research Services for Latvia

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, offer full-spectrum regulatory and research solutions for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies looking to enter the Latvia (EU) market.

Our services ensure full compliance with ZVA, EMA, EU Directives, and ICH/WHO requirements.

📘 Regulatory Services for Latvia

🇱🇻 Regulatory & Product Registration Support – Latvia (EU)

We support companies throughout the entire regulatory process for accessing the Latvian and broader European Union market, ensuring compliance with:

✔ ZVA – State Agency of Medicines of the Republic of Latvia
✔ EMA – European Medicines Agency
✔ EU Regulatory Framework
✔ ICH Guidelines (Q/S/E)

📘 Product Registration Services

• EU/Latvia Dossier Preparation & Product Approval

– EU-CTD dossier preparation for pharmaceutical (Rx/OTC) products
– Food supplement notification to the Food and Veterinary Service (PVD)
– Cosmetic product notification in the CPNP Portal
– Support for Herbal, Ayurveda, Nutraceutical, Veterinary product classification
– Ingredient compliance with:
✔ (EC) 1925/2006 – Nutrition & Health Claims
✔ (EC) 2015/2283 – Novel Foods
✔ (EC) 1223/2009 – Cosmetics

• Latvia/EU Label & Packaging Compliance

– Latvian-language label review (mandatory for Latvia market)
– Complete packaging compliance with EU Regulation 1169/2011
– Claims, warnings, allergens and mandatory information verification
– Multilingual artwork and IFU/leaflet preparation

📗 Drug Master File (DMF) / ASMF Services

– Preparation of EU-CTD Modules 2 & 3 for ASMF/DMF
– API documentation support as required by ZVA & EMA
– CEP (EDQM Certificate of Suitability) support
– EU-GMP & ICH Q8/Q9/Q10 compliant documentation

⚗️ Bioequivalence (BE) Study Support – EU/Latvia

– BE study design following EMA Guidelines
– Collaboration with EU-accredited CRO facilities
– Compilation of complete BE study reports for ZVA/EMA
– Dissolution comparison & biowaiver support (where applicable)

🔬 Analytical Method Validation (AMV) Services

– Validation per ICH Q2(R2) standards
– Method development: assay, dissolution, impurities, RS, stability
– Preparation of AMV protocols, raw data, and final validation reports
– QC support for product release and routine testing

🧾 Regulatory Consultancy & Compliance – Latvia

– Product classification guidance: pharma, supplement, cosmetic
– Importer/Distributor regulatory duties under EU rules
– GMP/GDP compliance support for Latvian wholesalers/importers
– Variations, renewals, PSUR & lifecycle maintenance
– Continuous updates on ZVA, EMA & EU regulation changes

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

💊 Formulation Development

– Tablets, capsules, liquids, syrups, powders, injectables
– Stability studies under EU Climate Zone II
– Optimization for EU product requirements and performance

🧫 Analytical R&D Services

– Assay, dissolution, impurity profiling
– QC method development & validation
– Real-time and accelerated stability studies

📑 Product Development Reports (PDRs)

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

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocols and reports compliant with ICH-GCP (E6)
– Toxicology assessment per OECD standards
– EU cosmetic safety documentation:
✔ PIF (Product Information File)
✔ CPSR (Cosmetic Product Safety Report)

🌏 Why Choose Us for the Latvia Market

• Expertise in ZVA, EMA & EU regulatory systems
• End-to-end product development & regulatory compliance
• Extensive experience across EU, US, ASEAN, and ROW markets
• Fast, high-quality CTD/ASMF preparation
• Tailored strategies for Latvian and EU regulatory pathways

📘 Regulatory & Dossier Documentation – Latvia/EU

Hashtags – Latvia & EU
#DossierLatvia #DMFLatvia #CTDLatvia #EUCTD #ASMF #ZVA
#RegulatoryLatvia #PharmaLatvia #PharmaComplianceEU
#StabilityStudiesEU #PSUR #CTReportEU #ToxicityReportEU
#BMR #MFR #PharmaValidationEU #PharmaQualityEU

⚗️ Bioequivalence & Analytical Studies – Latvia/EU

#BEStudiesEU #BioequivalenceStudyEU #AnalyticalMethodValidationEU
#AMVEU #AssayValidationEU #DissolutionValidationEU

🧪 Technology Transfer & Safety – Latvia/EU

#TechnologyTransferEU #AnalyticalTransferEU #MethodTransferEU
#MSDSEU #TechTransferEU

🌐 Top Pharma & Regulatory Hashtags – Latvia & EU

#PharmaLatvia #LatviaEU #ZVA #EUCTD #CPNP
#PharmaQualityEU #PharmaManufacturingEU #TechTransferEU
#StabilityStudiesEU #ClinicalTrialReportEU