BMRx – Global Batch Manufacturing Record (BMR) Services for Brunei Darussalam

Brunei-Compliant | WHO & ASEAN GMP Aligned | Inspection-Ready

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Batch Manufacturing Record (BMR) Preparation & Review Services for Brunei pharmaceutical, herbal, nutraceutical, cosmetic, food, and chemical manufacturers supplying to domestic, ASEAN, and international regulated markets.

Since 2008, BMRx has supported manufacturers across Asia, the Middle East, Europe, Africa, North America, and LATAM with regulatory-compliant, authority-acceptable BMR documentation, ensuring smooth registrations, inspection readiness, and reduced regulatory observations.

Who We Serve in Brunei

We work with Brunei-based organizations involved in:

• Manufacturing for the Brunei domestic market (Ministry of Health – Brunei Darussalam)
• Export to ASEAN, GCC, Australia, New Zealand, US & EU
• Halal-compliant manufacturing facilities
• Herbal, traditional medicine & nutraceutical producers
• Food, dietary supplement & cosmetic manufacturers
• Contract manufacturing & private-label production

Our BMR Services for Brunei Manufacturers

We provide complete lifecycle support for Batch Manufacturing Records, including:

✅ BMR Preparation

• Preparation of Brunei-compliant and export-oriented BMRs aligned with:
o Brunei MOH requirements
o WHO GMP Guidelines
o PIC/S GMP
o ASEAN GMP
o US FDA & EU GMP (for export-oriented products)
• Product-specific, process-driven, non-generic BMRs
• Clear documentation of materials, process steps, IPCs, yields, reconciliation, and deviations
• Operator-friendly, audit-ready formats

✅ BMR Review & GMP Compliance Check

• Independent technical and GMP review of existing BMRs
• Identification of:
o Missing GMP elements
o Documentation gaps affecting MOH or export approval
o Data-integrity and traceability risks
• Alignment with WHO, ASEAN, and importing-country expectations

✅ Regulatory Query & Inspection Support

• Support for Brunei MOH, ASEAN authorities, WHO & importing-country queries
• Assistance during:
o Product registration
o Export approvals
o GMP audits and inspections
• CAPA-linked BMR corrections and upgrades

✅ Gap Assessment & Remediation

• Gap analysis of existing BMRs against:
o WHO / ASEAN GMP standards
o Export-market documentation requirements
• Practical, shop-floor-executable corrective actions

✅ Customized BMR Templates

• Ready-to-use, regulator-accepted BMR templates
• Customized based on:
o Product type (pharma, herbal, food, cosmetic)
o Batch size & equipment
o Facility layout, utilities & halal requirements
o Domestic and export market goals

Our Global Experience (Supporting Brunei from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Strong experience supporting ASEAN and emerging-market manufacturers
• Extensive work across:
o Southeast Asia
o Middle East
o Africa
• Exposure to:
o Herbal & traditional medicines
o Nutraceuticals & food supplements
o Cosmetics & halal-compliant products
• Regular interaction with:
o WHO
o National Ministries of Health
o Importing-country regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• Brunei Ministry of Health requirements
• WHO GMP Guidelines
• PIC/S GMP Requirements
• ASEAN GMP Guidelines
• US FDA cGMP (for exports, where applicable)
• EU GMP (for exports, where applicable)
• ICH Q7 / Q9 (where applicable)

Industries We Support in Brunei

• Pharmaceuticals & Essential Medicines
• Herbal & Traditional Medicine Products
• Nutraceuticals & Food Supplements
• Food Processing & Ingredients
• Cosmetics & Personal Care
• Natural Extracts & Essential Oils
• Chemicals & Industrial Products (limited-scope GMP)

Why Brunei Manufacturers Choose BMRx

• 🌍 Strong WHO & ASEAN GMP documentation expertise
• 📋 Export-ready and authority-acceptable BMRs
• 🔍 Reduced registration & inspection observations
• 🧠 Experience with halal-compliant & emerging-market GMP needs
• 🛠️ Practical, non-generic, process-specific BMRs
• 🔒 Confidential, professional, and deadline-driven
• 👷 Simple, operator-friendly formats

How We Start the Project

To initiate BMR preparation or review, we typically require:

• Product details and formulation
• Manufacturing process & flow diagram
• Equipment list and batch size
• Target markets (domestic / ASEAN / export)
• Existing BMRs (if available)

Based on this, we provide:

• Customized technical scope
• Clear timelines
• Transparent commercial proposal

BMRx

Batch Manufacturing Records. Built for Compliance. Ready for Inspection.
Supporting Brunei manufacturers for ASEAN & global regulatory success