BMRx – Global Batch Manufacturing Record (BMR) Services for Laos (Lao PDR)

Laos-Compliant | WHO & ASEAN GMP Aligned | Export-Ready Documentation

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

Since 2008, BMRx has supported manufacturers across Southeast Asia, South Asia, the Middle East, Africa, Europe, and LATAM with regulatory-compliant, authority-acceptable BMR documentation, enabling product registration, GMP inspections, donor procurement, and export approvals.

Who We Serve in Laos

We work with Laos-based organizations involved in:

• Manufacturing for the Lao domestic market (Ministry of Health – Department of Food and Drug)
• Local pharmaceutical production units
• Herbal & traditional medicine manufacturers
• Nutraceutical, food supplement & dietary product producers
• NGO / donor / WHO-supported supply programs
• Export to ASEAN countries, China, South Asia, Africa & humanitarian markets

Our BMR Services for Lao Manufacturers

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

✅ BMR Preparation

• Preparation of Laos-compliant and export-oriented BMRs aligned with:
o Lao Ministry of Health requirements
o WHO GMP Guidelines
o ASEAN GMP
o PIC/S GMP (where applicable)
o US FDA / EU GMP (for export-oriented facilities)
• Product-specific, process-driven, non-generic BMRs
• Clear documentation of materials, processing steps, IPCs, yields, and reconciliation
• Simple, 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 impacting registration or export
o Data integrity and traceability risks
• Alignment with WHO, ASEAN, and importing-country expectations

✅ Regulatory Query & Inspection Support

• Support for Lao MOH, WHO, NGO, and importing-country authority queries
• Assistance during:
o Product registration
o WHO / donor audits
o Export approvals
• 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, floor-ready corrective actions suitable for developing facilities

✅ Customized BMR Templates

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

Our Global Experience (Supporting Laos from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Strong experience with ASEAN & emerging-market GMP environments
• Extensive work across:
o Southeast Asia
o South Asia
o Africa
• Exposure to:
o Essential medicines
o Herbal & traditional products
o Nutraceuticals & food supplements
• 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:

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

Industries We Support in Laos

• 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 Lao Manufacturers Choose BMRx

• 🌍 Strong WHO & ASEAN GMP documentation expertise
• 📋 Export-ready and authority-acceptable BMRs
• 🔍 Reduced registration, audit & inspection observations
• 🧠 Deep understanding of emerging-market GMP realities
• 🛠️ 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 / NGO supply)
• 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 Lao manufacturers for domestic, ASEAN & global regulatory success.