GlobalCOA – Brunei Darussalam

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

Brunei-Compliant COAs. MOH-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 Brunei Darussalam regulatory requirements for products manufactured in Brunei or imported into / exported from Brunei.

We support Brunei manufacturers, importers, exporters, government-linked companies, distributors, and international brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth regulatory approval and uninterrupted market access.

Regulatory Framework – Brunei Darussalam

GlobalCOA services are aligned with the regulatory and quality requirements of:

• Ministry of Health (MOH), Brunei Darussalam
• Department of Pharmaceutical Services (DPS)
• Brunei Medicines Control Authority (BMCA) (where applicable)
• ASEAN Pharmaceutical Product Working Group (PPWG)
• Brunei Customs Department
• Recognized international standards, including:
– WHO Guidelines & TRS
– British Pharmacopoeia (BP)
– United States Pharmacopeia (USP)
– European Pharmacopoeia (Ph. Eur.)
– Indian Pharmacopoeia (IP)
• ISO/IEC 17025–accredited testing laboratories (ILAC-recognized)

Our GlobalCOA Services – Brunei Darussalam

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

✅ COA Preparation (Brunei-Compliant)

• COA drafting as per MOH & DPS requirements
• Alignment with BP / USP / Ph. Eur. / IP as accepted by Brunei authorities
• Batch-wise, shipment-specific, and customer-specific COAs
• COAs suitable for:
– Product registration & approval dossiers
– Import permits & customs clearance
– Government and hospital procurement
– Export shipments

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for Brunei MOH & Customs acceptance
• Identification and correction of:
– Missing mandatory quality parameters
– Incorrect specifications or acceptance limits
– Unsupported or non-recognized test references
• Harmonization with:
– Product specifications
– Import & shipping documentation
– ASEAN-aligned technical dossiers

✅ Testing & Analytical Coordination (International)

• Testing coordination through international ISO/IEC 17025-accredited laboratories
• Method selection based on:
– BP / USP / Ph. Eur. / IP
– WHO-recommended analytical methods
– ASEAN-accepted test standards
– Validated in-house methods with scientific justification
• Support for:
– Re-testing and verification
– OOS / OOT investigations
– Quality justifications for MOH or customs queries

Product Categories Covered – Brunei Darussalam

GlobalCOA provides COA services for commonly regulated products:

🔹 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

🔹 Finished Products

• Pharmaceutical formulations (Rx & OTC)
• Vaccines & essential medicines
• Cosmetics & personal care products
• Herbal & traditional medicines
• Nutraceuticals, food supplements & fortified foods

🔹 Solvents & Processing Aids

• Residual and recovery solvents
• Cleaning and processing solvents
• Laboratory and industrial solvents

Industries We Serve – Brunei Darussalam

GlobalCOA supports stakeholders supplying regulated products to Brunei, including:

• Pharmaceutical exporters
• Government & hospital procurement bodies
• Food & nutraceutical suppliers
• Cosmetics & personal care brands
• Chemical & laboratory suppliers
• Trading & distribution companies

Why Choose GlobalCOA for Brunei Darussalam?

✔ Strong understanding of Brunei MOH & ASEAN regulatory expectations
✔ COAs aligned with WHO-accepted pharmacopoeias
✔ Import-ready documentation for customs & regulatory clearance
✔ Shipment-specific and audit-ready COAs
✔ Reduced risk of border delays and document rejection
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Import Support – Brunei Darussalam

GlobalCOA COAs support:

• Ministry of Health product approvals
• Import permits & customs clearance
• Government and hospital tenders
• ASEAN-aligned technical submissions
• Distributor and wholesaler requirements
• Quality audits and inspections

Our Brunei-focused COAs help reduce regulatory queries, prevent shipment delays, and ensure uninterrupted product supply.

Get Started with GlobalCOA – Brunei Darussalam

Whether you require new COA preparation, review of existing COAs, or testing coordination for products supplied to Brunei Darussalam, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted ASEAN-region compliance partner.

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