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

🇹🇼 Regulatory and Research Services for Taiwan

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, offer complete regulatory and research services for pharmaceutical, nutraceutical, herbal, cosmetic, food supplement, and veterinary companies entering the Taiwan market.

Our services comply with TFDA, MOHW, Taiwan GMP, Cosmetic Safety Act, Health Food Act, and international ICH/WHO standards.

📘 Regulatory Services for Taiwan

🇹🇼 Regulatory & Product Registration Support – Taiwan

We guide companies through all regulatory steps under:

✔ TFDA – Taiwan Food and Drug Administration
✔ MOHW – Ministry of Health and Welfare
✔ TDR – Taiwan Drug Registration database
✔ Taiwan Cosmetic Hygiene & Safety Law
✔ Health Food Control Act
✔ PIC/S GMP (Mandatory for pharma importers)
✔ ICH Q/S/E Guidelines

Taiwan has unique pathways for imported pharmaceuticals, health foods, OTC drugs, and cosmetics — all handled end-to-end.

📘 Product Registration Services

• Taiwan Dossier Preparation & Registration

– Imported Drug Registration in TFDA CTD format
– Prescription & OTC registration
– Health Food registration (functional claims + clinical data)
– Health Food Filing (simpler notification pathway—if eligible)
– Cosmetic product registration/notification per Cosmetic Safety Act
– Herbal, TCM, traditional medicine registration
– Ingredient compliance with TFDA restricted / prohibited lists
– Safety, stability, and efficacy documentation preparation

• Taiwan Label & Packaging Compliance

– Mandatory Traditional Chinese labeling
– Claims & warnings compliance with TFDA rules
– Cosmetics labeling as per TFDA Cosmetic Hygiene Safety Act
– IFU/leaflets, packaging, and artwork preparation

📗 Drug Master File (DMF) / API Documentation – Taiwan

– Taiwan DMF filing in CTD format
– ChP/USP/EP alignment verification
– CEP/US DMF bridging for Taiwan submissions
– PIC/S GMP documentation (mandatory for approval)
– API stability, impurity & quality documentation for TFDA approval

⚗️ Bioequivalence (BE) Study Support – Taiwan

– BE study protocols per TFDA + ICH guidelines
– Coordination with TFDA-licensed CROs
– Acceptance of foreign BE studies in certain categories
– Biowaiver support for BCS Class I/III APIs
– Complete BE reporting for TFDA evaluation

🔬 Analytical Method Validation (AMV) Services

– AMV as per ICH Q2(R2) + Taiwan-specific QC requirements
– Validation of assay, impurities, dissolution, stability
– AMV protocol + raw data + final validation report
– Method transfer for Taiwan import-release testing labs

🧾 Regulatory Consultancy & Compliance – Taiwan

– Product classification (Drug / Health Food / Cosmetic / TCM / Veterinary)
– Local Taiwan Authorized Holder guidance
– GMP/GDP regulatory requirements for importers
– Post-approval: variations, renewals, safety reports
– Monitoring TFDA, MOHW & TIPS ingredient list updates

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

💊 Formulation Development

– Tablets, capsules, liquids, powders, injectables
– Stability studies for Subtropical/Tropical climate (similar to Zone IV)
– Taiwan-specific excipient & contaminant compliance

🧫 Analytical R&D Services

– Assay, impurities, dissolution, stability
– QC method development & validation
– Real-time & accelerated stability per TFDA rules

📑 Product Development Reports (PDRs)

– PDR prepared in TFDA CTD format
– Includes formulation, analytical methods, and stability data

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documents per ICH-GCP (E6)
– Assistance with TFDA clinical trial submissions
– Toxicology studies (OECD compliant) accepted by TFDA
– Cosmetic safety reports per Taiwan Cosmetic Safety Act
– Health Food functional claim substantiation (often requires human study)

🌏 Why Choose Us for the Taiwan Market

• Strong expertise with TFDA, MOHW, TDR & Taiwan Cosmetic Safety Law
• End-to-end regulatory, documentation & quality support
• Experience across Taiwan, China, Japan, ASEAN, GCC, EU, US & ROW
• Accurate classification ensures faster approval
• CTD/DMF/AMV expertise tailored to Taiwan regulatory expectations

📘 Regulatory & Dossier Documentation – Taiwan

Hashtags – Taiwan Market
#DossierTaiwan #TFDA #TaiwanDrugRegistration
#TaiwanCosmetics #HealthFoodTaiwan #TCMTaiwan
#CTDTaiwan #DMFTaiwan #PharmaTaiwan
#PharmaComplianceAsia #StabilityStudiesTaiwan #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Taiwan

#BEStudiesTaiwan #BioequivalenceTaiwan #AMV
#AnalyticalMethodValidation #DissolutionValidation

🧪 Technology Transfer & Safety – Taiwan

#TechnologyTransferTaiwan #MethodTransfer #MSDS
#PharmaTechTransferTaiwan