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

🇨🇳 Regulatory and Research Services for China

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

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

Our services align strictly with NMPA, SAMR, CSAR, Health Food Registration, and ICH/WHO global guidelines.

📘 Regulatory Services for China

🇨🇳 Regulatory & Product Registration Support – China

We support companies across all China regulatory pathways in accordance with:

✔ NMPA – National Medical Products Administration
✔ SAMR – Market Regulation Authority (Food Supplements, Health Food)
✔ GACC – Customs Import Compliance
✔ MOH/MARA – Herbal, TCM, and Veterinary products
✔ China Pharmacopeia (ChP)
✔ China GMP/GDP regulations
✔ ICH Q/S/E Guidelines

China has unique regulatory systems—especially for health foods, TCM, cosmetics, and imported pharmaceuticals—and we handle all steps end-to-end.

📘 Product Registration Services

• China Dossier Preparation & Product Registration

– Imported drug registration under NMPA (CTD-based Chinese format)
– MAH (Marketing Authorization Holder) registration support
– Health Food (“Blue Hat”) registration & filing
– TCM / Herbal medicine registration
– Cosmetic registration under CSAR 2021 (new regulation)
– Veterinary drug registration with MARA
– Ingredient compliance verification (permitted, restricted, prohibited lists)

• China Label & Packaging Compliance

– Mandatory Simplified Chinese labeling
– Compliance with NMPA, SAMR & CSAR cosmetic labeling standards
– Verification of claims, warnings, allergen declarations, and nutrition information
– Artwork preparation, IFU, leaflet formatting as per China rules

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

– China DMF filing (Active Pharmaceutical Ingredient Registration Platform)
– ChP-based quality documentation
– ICH Q8/Q9/Q10 technical documents adapted to NMPA format
– CEP/US DMF bridging support
– GMP documentation per Chinese GMP requirements
– API import approval support

⚗️ Bioequivalence (BE) Study Support – China

– BE study protocol design per NMPA + ICH guidelines
– BE studies conducted in NMPA-certified China CROs
– Acceptance of foreign BE studies in some categories with bridging
– Biowaiver (Class I/III) justification support
– Complete BE report preparation for NMPA review

🔬 Analytical Method Validation (AMV) Services

– AMV according to ChP + ICH Q2(R2)
– Analytical method development for:
• assay
• impurities
• dissolution
• degradation
• stability
– AMV protocols, raw data, and final validation reports
– QC method transfer for China import testing

🧾 Regulatory Consultancy & Compliance – China

– Classification: Medicine / Health Food / TCM / Cosmetic / Veterinary
– Chinese MAH compliance guidance
– GMP & manufacturing site inspection support
– GACC import compliance for finished products
– Post-approval lifecycle management: variations, renewals, safety monitoring
– Regulatory intelligence on NMPA/SAMR/CSAR updates

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

💊 Formulation Development

– Tablets, capsules, syrups, powders, injectables
– Stability studies per Zone II/IVb (China climate regions)
– Optimization for Chinese market & excipient regulations

🧫 Analytical R&D Services

– Assay, impurity profiling, dissolution, stability testing
– Method development & validation per ChP/ICH
– Stability studies (real-time and accelerated)

📑 Product Development Reports (PDRs)

– China CTD-format PDR preparation
– Includes formulation development, QC methods, stability data

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocol, IB, CSR as per ICH-GCP + NMPA
– Phase I–IV clinical trial regulatory submission support
– Toxicology studies per OECD guidelines (accepted by NMPA)
– Cosmetic safety reports under CSAR:
✔ Ingredient safety assessment
✔ Toxicology bridging data
✔ Product safety compliance

🌏 Why Choose Us for the China Market

• Experts in NMPA, SAMR, CSAR & China Health Food registration
• End-to-end regulatory, technical, and documentation support
• Deep understanding of China-specific dossier formats & testing requirements
• Strong experience across China + ASEAN + GCC + EU + US
• Faster approval timelines through correct strategy & classification

📘 Regulatory & Dossier Documentation – China

Hashtags – China Market
#DossierChina #NMPA #ChP #ChinaDMF #CTDChina
#PharmaChina #ChineseRegulation #CSARChina
#ImportedDrugChina #HealthFoodChina
#TCMChina #CosmeticsChina #VeterinaryChina
#PharmaComplianceChina #StabilityStudiesChina #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – China

#BEStudiesChina #BioequivalenceChina #AMVChina
#AnalyticalMethodValidationChina #DissolutionValidationChina

🧪 Technology Transfer & Safety – China

#TechnologyTransferChina #MethodTransferChina
#MSDSChina #PharmaTechTransferChina