BMRx – Global Batch Manufacturing Record (BMR) Services for Tonga

Tonga-Compliant | Global 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 Tongan pharmaceutical, herbal, nutraceutical, cosmetic, food, and chemical manufacturers supplying to domestic, regional, and international regulated markets.

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

Who We Serve in Tonga

We work with Tonga-based organizations involved in:

• Manufacturing for the Tongan domestic market (Ministry of Health – Tonga)
• Export to Pacific Islands, Australia, New Zealand, ASEAN, US & EU
• Herbal, natural medicine & nutraceutical manufacturing
• Food and dietary supplement production
• Cosmetics & personal care products
• Contract manufacturing & private label production
• WHO / donor-funded supply programs

Our BMR Services for Tongan Manufacturers

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

✅ BMR Preparation

• Preparation of Tonga-compliant and export-oriented BMRs aligned with:
o Tonga Ministry of Health requirements
o WHO GMP Guidelines
o PIC/S GMP
o US FDA (where applicable for exports)
o EU GMP (where applicable)
• Product-specific, process-driven, non-generic BMRs
• Clear documentation of raw material control, process steps, IPCs, yields, and reconciliation
• Operator-friendly, inspection-ready formats

✅ BMR Review & GMP Compliance Check

• Independent technical and GMP review of existing BMRs
• Identification of:
o Missing GMP elements
o Documentation and traceability gaps
o Export-market compliance risks
• Alignment with current WHO and importing-country expectations

✅ Regulatory Query & Inspection Support

• Support for MOH Tonga / WHO / importing-country authority queries
• Assistance during:
o Product registration
o Export approvals
o Audits and inspections
• CAPA-linked BMR corrections

✅ Gap Assessment & Remediation

• Gap analysis of existing BMRs against:
o WHO GMP & PIC/S expectations
o Australia / New Zealand / US / EU export requirements
• Practical, floor-executable corrective actions

✅ Customized BMR Templates

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

Our Global Experience (Supporting Tonga from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Strong experience with small and emerging manufacturing facilities
• Extensive work across:
o Pacific Islands
o Africa
o Southeast Asia
• Exposure to:
o Herbal & traditional medicines
o Nutraceuticals & food supplements
o Cosmetics & natural 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:

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

Industries We Support in Tonga

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

Why Tongan Manufacturers Choose BMRx

• 🌍 Export-oriented BMRs accepted internationally
• 📋 WHO-aligned, inspection-ready documentation
• 🔍 Reduced regulatory and audit observations
• 🧠 Strong experience with emerging & island-market GMP needs
• 🛠️ Non-generic, practical, 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 export markets (if any)
• 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 Tongan manufacturers for regional & global regulatory success