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

🇨🇭 Regulatory and Research Services for Switzerland

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, provide comprehensive regulatory and research support for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Swiss market.

Our solutions ensure compliance with Swissmedic, FSVO, FOPH, Swiss Therapeutic Products Act, and ICH/WHO standards.

📘 Regulatory Services for Switzerland

🇨🇭 Regulatory & Product Registration Support – Switzerland

We support companies through the full Swiss authorization pathway, aligned with:

✔ Swissmedic – Swiss Agency for Therapeutic Products (Medicines & Medical Devices)
✔ FSVO (Federal Food Safety & Veterinary Office) – Supplements, Veterinary Products
✔ FOPH – Federal Office of Public Health
✔ Cantonal Health Authorities (as required)
✔ Swiss Law on Therapeutic Products (TPA)
✔ ICH Q/S/E Guidelines

Switzerland is not in the EU, so registrations must follow Swiss-specific national rules.

📘 Product Registration Services

• Switzerland Dossier Preparation & Registration

– Swissmedic eCTD dossier preparation for Rx/OTC products
– Support for procedures:
✔ Authorization of human medicines
✔ Simplified authorization (HMP, traditional herbal)
✔ Fast-track / temporary / export-only authorizations
– Food supplement compliance with FSVO
– Cosmetic notification according to the Swiss Cosmetics Regulation (based on EU 1223/2009 but under Swiss law)
– Veterinary product registration under FSVO/Swissmedic
– Ingredient & claims evaluation based on:
✔ Swiss Foodstuffs Act (Food Supplements)
✔ Swiss Therapeutic Products Act
✔ EU-derived cosmetic safety rules (adapted to Swiss law)

• Switzerland Label & Packaging Compliance

– Mandatory German / French / Italian labeling (depending on canton)
– Packaging compliance according to Swiss Foodstuffs Ordinance
– Verification of allergen, nutrition, botanical & health claims
– Cosmetic labeling per Swiss Cosmetics Ordinance
– Artwork & IFU (Instructions for Use) preparation

📗 Drug Master File (DMF) / API Submission – Switzerland

– Preparation of Swissmedic-compliant DMF/ASMF
– EU/US DMF adaptation to Swiss format
– ICH Q8/Q9/Q10-compliant technical documentation
– CEP (EDQM) support for Swiss registrations
– Manufacturer GMP compliance verification for Swiss importers

⚗️ Bioequivalence (BE) Study Support – Switzerland

– BE study protocol design per Swissmedic + ICH + EMA guidelines
– Acceptable BE studies from EMA/WHO/EU-approved CROs
– Complete BE study report preparation for Swissmedic
– Biowaiver evaluation (BCS Class I/III)

🔬 Analytical Method Validation (AMV) Services

– Validation per ICH Q2(R2)
– Assay, dissolution, impurity & stability method validation
– AMV protocol + validation report for Swissmedic submissions
– QC documentation for product release into Switzerland

🧾 Regulatory Consultancy & Compliance – Switzerland

– Product classification:
✔ Medicine
✔ Food Supplement (Foodstuffs)
✔ Cosmetic
✔ Herbal Remedy
✔ Veterinary Product
– Responsible Person (RP) support for Switzerland
– GMP/GDP compliance assistance for Swiss importers & wholesalers
– Swissmedic lifecycle management:
✔ Variations
✔ Renewals
✔ PSUR / RMP submissions
– Monitoring of updates to Swissmedic, FSVO & FOPH regulations

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

💊 Formulation Development

– Tablets, capsules, syrups, liquids, injectables
– Stability studies aligned with Swiss climatic conditions
– Formulation optimization for Swiss quality expectations

🧫 Analytical R&D Services

– Assay, impurity profiling, dissolution
– Method development & validation
– Stability studies (real-time, accelerated) under Swiss guidelines

📑 Product Development Reports (PDRs)

– CTD-format PDRs tailored for Swissmedic
– Process development, QC testing & stability summaries included

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documentation as per ICH-GCP (E6) + Swissmedic requirements
– Toxicology assessments following OECD standards
– Cosmetic safety documentation:
✔ Safety assessment
✔ Ingredient review
✔ PIF-style documentation (optional in Switzerland)

🌏 Why Choose Us for the Switzerland Market

• Deep expertise in Swissmedic, FSVO & Swiss national regulations
• End-to-end technical & regulatory documentation support
• Strong global experience across EU, US, GCC, ASEAN, Pacific & ROW
• Fast & compliant CTD/DMF submissions
• Tailored strategies for Swiss-specific regulatory pathways (non-EU)

📘 Regulatory & Dossier Documentation – Switzerland

Hashtags – Switzerland Market
#DossierSwitzerland #DMFSwitzerland #CTDSwitzerland
#Swissmedic #FSVO #FOPH
#RegulatorySwitzerland #PharmaSwitzerland
#CosmeticsSwitzerland #FoodSupplementSwitzerland
#VeterinarySwitzerland #StabilityStudiesSwitzerland
#PharmaComplianceCH #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Switzerland

#BEStudiesCH #BioequivalenceSwitzerland #AMVSwitzerland
#AssayValidationEU #DissolutionValidationEU

🧪 Technology Transfer & Safety – Switzerland

#TechTransferSwitzerland #AnalyticalTransferEU
#MethodTransferEU #MSDSCH #PharmaTechTransferCH

🌐 Top Pharma & Regulatory Hashtags – Switzerland

#PharmaCH #SwissRegulatory #Swissmedic #CHCompliance
#CTDSwitzerland #DMFSwitzerland #PharmaQualityCH
#ClinicalTrialsSwitzerland #StabilityStudiesCH