GlobalCOA – New Zealand

Certificate of Analysis (COA) Preparation, Review & Testing Services

New Zealand–Compliant COAs. Medsafe-Ready. Import & Export-Focused.

GlobalCOA, a professional service brand of Zoesoe Exports Pvt Ltd, provides end-to-end Certificate of Analysis (COA) preparation, review, and testing coordination services in accordance with New Zealand regulatory requirements for products manufactured in New Zealand or imported into / exported from New Zealand.

We support New Zealand manufacturers, importers, exporters, distributors, and international brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth regulatory approval and global market acceptance.

Regulatory Framework – New Zealand

GlobalCOA services are aligned with the requirements of:

Medsafe – New Zealand Medicines and Medical Devices Safety Authority
Ministry of Health – New Zealand
New Zealand Pharmacopoeial references (BP / Ph. Eur. / USP as accepted by Medsafe)
Environmental Protection Authority (EPA)
Ministry for Primary Industries (MPI) – food & nutraceutical oversight
Good Manufacturing Practice (GMP – PIC/S aligned)
IANZ / ISO/IEC 17025-accredited testing laboratories

Our GlobalCOA Services – New Zealand

We provide complete lifecycle support for Certificate of Analysis documentation in line with New Zealand regulatory expectations:

COA Preparation (New Zealand-Compliant)

• COA drafting as per Medsafe & Ministry of Health requirements
• Alignment with BP / Ph. Eur. / USP / IP for imported and export-oriented products
Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for:
– Medsafe product registration dossiers
– Import permits & customs clearance
– Export shipments
– Distributor, tender, and partner submissions

COA Review & Regulatory Compliance Assessment

• Review of existing COAs for Medsafe / GMP compliance
• Identification and correction of:
– Missing mandatory parameters
– Incorrect specifications or acceptance limits
– Unsupported non-pharmacopoeial test methods
• Harmonization with:
– Product specifications
CTD / NZ-CTD dossiers
– DMFs / ASMFs
– Import & registration documentation

Testing & Analytical Coordination – New Zealand

• Testing coordination through IANZ-accredited & Medsafe-recognized laboratories
• Method selection based on:
– BP / Ph. Eur. / USP
– ICH-aligned analytical methods
– Validated in-house methods with scientific justification
• Support for:
– Re-testing and verification
OOS / OOT investigations
– Trend analysis and Medsafe regulatory responses

Product Categories Covered – New Zealand

GlobalCOA provides COA services across key regulated product categories:

🔹 Raw Materials

• APIs and pharmaceutical actives
• Excipients
• Herbal and botanical raw materials
• Chemical intermediates

🔹 Packaging Materials

• Primary pharmaceutical packaging
• Secondary and tertiary packaging
Food-contact and cosmetic-contact materials (MPI/EPA compliant)

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Biotechnology & biologics products
• Natural health products
• Cosmetics & personal care products
• Nutraceuticals, food ingredients, and dietary supplements

🔹 Solvents & Processing Aids

• Residual and recovery solvents
• Cleaning and processing solvents
• Industrial and laboratory solvents

Industries We Serve – New Zealand

GlobalCOA supports regulated industries across New Zealand, including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Natural health & herbal products
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Specialty & Industrial Chemicals
• Export-oriented manufacturers

Why Choose GlobalCOA for New Zealand?

✔ Strong understanding of Medsafe & New Zealand GMP expectations
✔ COAs aligned with BP, Ph. Eur., USP & ICH guidelines
✔ Seamless coordination with IANZ-accredited laboratories
Import-ready and export-ready COAs
✔ Audit-ready, inspection-friendly documentation
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – New Zealand

GlobalCOA COAs support:

• Medsafe product registrations & lifecycle variations
• Import permits & customs clearance
• Export documentation for Australia, EU, UK, US & Asia-Pacific markets
• CTD / NZ-CTD & DMF submissions
• Distributor, partner, and tender requirements
• Regulatory inspections and quality audits

Our New Zealand-focused COAs help reduce regulatory queries, prevent shipment delays, and ensure uninterrupted market access.

Get Started with GlobalCOA – New Zealand

Whether you require new COA preparation, review of existing COAs, or testing coordination for products manufactured in or exported from New Zealand, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted Oceania compliance partner.

📩 Contact us today to discuss your product category, New Zealand regulatory pathway, and COA requirements.