Regulatory And Research Services for Regulatory-Services-Coverage-by-New Zealand-Market
🇳🇿 Regulatory and Research Services for New Zealand
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 entering the New Zealand market.
Our services align with Medsafe, MPI (NZ Food Safety), EPA, NZ Cosmetic Regulations, and ICH/WHO standards.
📘 Regulatory Services for New Zealand
🇳🇿 Regulatory & Product Registration Support – New Zealand
We support companies through all stages of registration and compliance with:
✔ Medsafe – Medicines & Medical Devices Safety Authority
✔ MPI – Ministry for Primary Industries / New Zealand Food Safety
✔ EPA – Environmental Protection Authority (Cosmetics & Ingredients)
✔ ACVM – Agricultural Compounds & Veterinary Medicines (Veterinary)
✔ ICH & WHO International Standards
📘 Product Registration Services
• New Zealand Dossier Preparation & Registration
– Medsafe CTD-format dossier preparation for pharmaceuticals (licensed/unlicensed medicines)
– Food Supplement / Dietary Supplement compliance under NZFS rules
– Cosmetic product compliance under NZ Cosmetic Products Group Standard 2020
– Herbal, Ayurvedic, nutraceutical & natural health product support
– Ingredient compliance checks based on:
✔ NZ Cosmetic Group Standard (EU-like positive/negative lists)
✔ NZ Food Standards Code
✔ Medsafe/NZ Medicines Act
✔ ACVM Veterinary Product Regulations
• New Zealand Label & Packaging Compliance
– English-language labeling (mandatory)
– Compliance with NZ requirements for:
✔ Supplement labels & nutrition information
✔ Cosmetic warning & ingredient declarations
✔ Pharmaceutical leaflets and packaging (Medsafe-approved)
– Artwork & IFU review as per NZ guidelines
📗 Drug Master File (DMF) / API Registration
– DMF/ASMF submission support for Medsafe
– Adapting EU/US DMFs to NZ CTD format
– API documentation aligned with ICH Q-series guidelines
– Support for API import compliance for New Zealand manufacturers
⚗️ Bioequivalence (BE) Study Support – New Zealand
– BE study protocol design following ICH + Medsafe + EMA aligned standards
– Coordination with accredited CROs (NZ/EU/India)
– Preparation of BE reports for Medsafe submission
– Biowaiver support for BCS-based submissions
🔬 Analytical Method Validation (AMV) Services
– Validation as per ICH Q2(R2)
– Assay, impurity, dissolution & stability method development
– AMV protocol + final validation report preparation
– QC support for NZ importers and manufacturers
🧾 Regulatory Consultancy & Compliance – New Zealand
– Product classification: medicine, dietary supplement, cosmetic
– Medsafe “New Medicines” evaluation support
– Natural Health Products (NHP) classification guidance
– GMP/GDP requirements for NZ-based importers & distributors
– Assistance with variations, renewals & post-approval updates
– Monitoring of Medsafe/MPI/EPA regulatory changes
🧪 Research & Development (R&D) Services – New Zealand Market
💊 Formulation Development
– Tablets, capsules, syrups, liquids, powders, injectables
– Stability studies aligned to New Zealand climate conditions
– Bioavailability optimization for NZ regulatory expectations
🧫 Analytical R&D Services
– Assay, dissolution, impurity profiling
– QC method development and validation
– Stability studies (real-time & accelerated)
📑 Product Development Reports (PDRs)
– PDRs prepared in CTD format
– Includes manufacturing process, analytical results & stability data
🧍⚕️ Clinical Trial & Toxicology Support
– Clinical trial protocols & final reports per ICH-GCP guidelines
– Assistance with NZ ethics committee requirements
– Toxicology evaluations following OECD guidelines
– Cosmetic safety compliance:
✔ Ingredient risk assessment
✔ Safety justification for NZ Cosmetic Standard
✔ PIF-style documentation (optional but recommended)
🌏 Why Choose Us for the New Zealand Market
• Experts in Medsafe, MPI, EPA, and NZ regulatory pathways
• End-to-end technical, regulatory & documentation support
• Strong experience across EU, US, ASEAN, GCC & ROW
• Fast, accurate CTD/DMF preparation
• Tailored strategies for medicines, supplements & cosmetics
📘 Regulatory & Dossier Documentation – New Zealand
Hashtags – New Zealand Market
#DossierNZ #DMFNZ #CTDNZ #MedsafeNZ #NZFoodSafety
#RegulatoryNZ #PharmaNewZealand #CosmeticsNZ
#DietarySupplementsNZ #NaturalHealthProductsNZ
#StabilityStudiesNZ #ClinicalTrialsNZ
#PharmaComplianceNZ #BMR #MFR
⚗️ Bioequivalence & Analytical Studies – NZ
#BEStudiesNZ #BioequivalenceNZ #AnalyticalMethodValidationNZ
#AMVNZ #DissolutionValidation #AssayValidation
🧪 Technology Transfer & Safety – NZ
#TechnologyTransferNZ #MethodTransferNZ #AnalyticalTransferNZ
#PharmaTechTransferNZ #MSDSNZ
🌐 Top Pharma & Regulatory Hashtags – New Zealand
#PharmaNZ #Medsafe #NewZealandRegulation #CTDNZ #DMFNZ
#NaturalHealthNZ #NZCosmetics #MPI #EPA