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

🇱🇹 Regulatory and Research Services for Lithuania

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, provide complete regulatory and research support to pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies seeking to enter the Lithuania (EU) market.

Our services follow the requirements of VVKT, EMA, EU Commission Regulations, and ICH/WHO guidelines.

📘 Regulatory Services for Lithuania

🇱🇹 Regulatory & Product Registration Support – Lithuania (EU)

We assist companies through the entire process of regulatory submission and product approval for the Lithuanian and wider European Union market, in accordance with:

✔ VVKT – State Medicines Control Agency of Lithuania
✔ EMA – European Medicines Agency
✔ EudraLex (EU Pharma Law)
✔ ICH Quality, Safety & Efficacy Guidelines

📘 Product Registration Services

• EU/Lithuania Dossier Preparation & Registration

– EU-CTD dossiers for pharmaceutical products (Rx/OTC)
– Food supplement notification to the Lithuanian Ministry of Health / NMVRVI
– Cosmetic product notification via CPNP (EU Cosmetic Portal)
– Herbal, Ayurveda, Nutraceutical, Veterinary product regulatory compliance
– Ingredient & claims review under EU standards:
✔ Regulation (EC) 1925/2006 – Nutrition/Health
✔ Regulation (EC) 2015/2283 – Novel Food
✔ Regulation (EC) 1223/2009 – Cosmetics

• Lithuania/EU Label & Packaging Compliance

– Lithuanian-language label review (mandatory for Lithuania market)
– Full labeling compliance with EU 1169/2011 Food Information Regulation
– Verification of warnings, allergens, allowed claims
– Multilingual label, artwork & IFU/leaflet preparation

📗 Drug Master File (DMF) / ASMF Services

– Compilation of EU-CTD Modules 2 & 3 for ASMF/DMF submission
– API documentation preparation as required by VVKT & EMA
– Support for CEP (Certificate of Suitability)
– Full ICH Q8/Q9/Q10-based documentation for EU regulatory acceptance
– Support for API manufacturers and EU importers

⚗️ Bioequivalence (BE) Study Support – EU/Lithuania

– BE study protocol design per EMA Guidelines
– Coordination with accredited EU CROs
– Preparation of BE study reports for VVKT/EMA
– Support for dissolution comparison and biowaiver justifications

🔬 Analytical Method Validation (AMV) Services

– Validation in accordance with ICH Q2(R2)
– Analytical methods for assay, dissolution, impurities, stability
– AMV protocol, raw data, and finalized validation report preparation
– QC technical support for EU market product release

🧾 Regulatory Consultancy & Compliance – Lithuania

– Product classification (pharma / supplement / cosmetic / veterinary)
– Importer/Distributor obligations under Lithuanian & EU laws
– GMP/GDP support for Lithuanian importers and distributors
– Variations, renewals, PSUR, and post-approval lifecycle maintenance
– Monitoring regulatory updates from VVKT, EMA & EU Commission

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

💊 Formulation Development

– Tablets, capsules, liquids, syrups, powders, injectables
– EU Zone II stability studies
– Product optimization for EU climate and performance requirements

🧫 Analytical R&D Services

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

📑 Product Development Reports (PDRs)

– PDR preparation in EU-CTD format
– Includes formulation development, process flow, analytical data & stability summaries

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocol design & reporting per ICH-GCP (E6)
– Toxicology studies aligned with OECD guidelines
– Cosmetic compliance documentation:
✔ PIF (Product Information File)
✔ CPSR (Cosmetic Product Safety Report)

🌏 Why Choose Us for the Lithuania Market

• Expertise in VVKT, EMA & EU regulatory frameworks
• End-to-end regulatory, technical & documentation support
• Strong experience across EU, US, ASEAN & ROW markets
• Fast and compliant CTD/ASMF preparation
• Market-specific regulatory strategies tailored for Lithuania

📘 Regulatory & Dossier Documentation – Lithuania/EU

Hashtags – Lithuania & EU
#DossierLithuania #DMFLithuania #CTDLithuania #EUCTD #ASMF #VVKT
#RegulatoryLithuania #PharmaLithuania #PharmaComplianceEU
#StabilityStudiesEU #PSUR #ClinicalTrialReportEU
#PharmaValidationEU #BMR #MFR #TechTransferEU

⚗️ Bioequivalence & Analytical Studies – Lithuania/EU

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

🧪 Technology Transfer & Safety – Lithuania/EU

#TechnologyTransferEU #PharmaTechTransferEU
#AnalyticalTransferEU #MethodTransferEU #MSDSEU

🌐 Top Pharma & Regulatory Hashtags – Lithuania & EU

#PharmaLithuania #LithuaniaEU #VVKT #EUCTD #CPNP
#PharmaManufacturingEU #PharmaQualityEU
#StabilityStudiesEU #ClinicalTrialReportEU