Regulatory And Research Services for Regulatory-Services-Coverage-by-Israel-Market
🇮🇱 Regulatory and Research Services for Israel
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, provide full regulatory and research support for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Israel market.
Our services ensure compliance with Israel Ministry of Health (MOH), AMAR, SII, IVC, and global ICH/WHO requirements.
📘 Regulatory Services for Israel
🇮🇱 Regulatory & Product Registration Support – Israel
We support companies at every stage of product approval and registration with:
✔ MOH – Ministry of Health Israel
✔ AMAR – Medical Devices & Medical Products Division
✔ Department of Food Control & National Food Service
✔ IVC – Veterinary Services
✔ SII – Standards Institution of Israel
📘 Product Registration Services
• Israel Dossier Preparation & Product Registration
– MOH/AMAR dossier preparation for pharmaceuticals (Rx/OTC)
– Food supplement notification & registration with Israel MOH
– Cosmetic product notification under Israel’s updated Cosmetics Law (based on EU Model)
– Support for Herbal, Ayurveda, Nutraceutical, Veterinary product approval
– Ingredient & claims compliance based on:
✔ Israel Cosmetic Law 2010 (updated with EU 1223/2009 alignment)
✔ Israel Food Supplements Regulations
✔ Israel Novel Foods Registration Requirements
✔ MOH Pharmaceutical Registration Directives
• Israel Label & Packaging Compliance
– Hebrew label review (mandatory)
– Regulatory verification of allergens, warnings, nutritional claims
– Compliance with Israel Food Labeling Standard (SII 1145)
– Bilingual and trilingual packaging (English/Hebrew/Arabic) if required
– IFU/leaflet development in Hebrew
📗 Drug Master File (DMF) / API Registration Services
– DMF compilation for Israel MOH submission (CTD-format accepted)
– Bridging EU/US DMFs to MOH requirements
– Support for API import compliance & quality documentation
– ICH Q8–Q10 compliant technical dossier preparation
– Liaison with MOH for API acceptance and registration
⚗️ Bioequivalence (BE) Study Support – Israel
– BE study design as per MOH + ICH + EMA hybrid guidelines
– Coordination with certified CROs (Israel/EU/India)
– Preparation of BE study reports for MOH submission
– Biowaiver support for BCS Class I/III drugs (where applicable)
🔬 Analytical Method Validation (AMV) Services
– AMV according to ICH Q2(R2)
– Method development for assay, impurity, dissolution, stability
– AMV protocol, raw data, and final validation report preparation
– QC support for Israeli importers & manufacturers
🧾 Regulatory Consultancy & Compliance – Israel
– Guidance on classification (Drug, Food Supplement, Cosmetic, Veterinary)
– Support for Local Regulatory Agent / Importer requirements
– GMP/GDP support for Israeli importers & distributors
– Handling variations, renewals, PSUR, annual product updates
– Ongoing regulatory monitoring of MOH Israel updates
🧪 Research & Development (R&D) Services – Israel Market
💊 Formulation Development
– Tablets, capsules, liquids, powders, syrups, injectables
– Middle-East climate stability studies (adapted to Israel climate zones)
– Bioavailability optimization & formulation improvement
🧫 Analytical R&D Services
– Assay, dissolution, impurity profiling
– Method development & validation
– Stability (real-time & accelerated) studies for MOH submissions
📑 Product Development Reports (PDRs)
– CTD-format PDRs for Israel registration
– Process development, analytical summary & stability data included
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical trial protocols & reports per ICH-GCP (E6)
– Support for MOH clinical trial submissions
– Toxicology reports following OECD Guideline
– Cosmetic PIF preparation + safety assessments for Israel market
🌏 Why Choose Us for the Israel Market
• Experts in MOH/AMAR Israel regulatory pathways
• End-to-end regulatory & technical documentation support
• Strong experience with EU, US, ASEAN & Middle East markets
• High-quality and fast CTD/DMF dossier preparation
• Customized strategies for pharmaceuticals, supplements, and cosmetics
📘 Regulatory & Dossier Documentation – Israel
Hashtags – Israel Market
#DossierIsrael #DMFIsrael #CTDIsrael #MOHIsrael #AMAR
#PharmaIsrael #RegulatoryIsrael #PharmaComplianceIsrael
#FoodSupplementIsrael #CosmeticsIsrael #PIFIsrael
#StabilityStudiesIsrael #ClinicalTrialIsrael #PSUR
#ProcessValidationIsrael #BMR #MFR
⚗️ Bioequivalence & Analytical Studies – Israel
#BEStudiesIsrael #BioequivalenceIsrael #AnalyticalMethodValidationIsrael
#AMVIsrael #DissolutionValidation #AssayValidation
🧪 Technology Transfer & Safety – Israel
#TechnologyTransferIsrael #AnalyticalTransferIsrael #MethodTransferIsrael
#MSDSIsrael #PharmaTechTransferIsrael
🌐 Top Pharma & Regulatory Hashtags – Israel
#PharmaIsrael #IsraelMOH #AMARIsrael #SIIIsrael
#CosmeticsIsrael #FoodSupplementsIsrael
#MiddleEastRegulatory #CTDIsrael #DMFIsrael