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

Rwanda-Compliant | WHO & EAC Aligned | Export & Procurement-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 Rwandan pharmaceutical, herbal, nutraceutical, cosmetic, food, and chemical manufacturers supplying to domestic, regional (EAC), humanitarian, and international markets.

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

Who We Serve in Rwanda

We work with Rwanda-based organizations involved in:

• Manufacturing for the Rwanda domestic market
(Rwanda Food and Drugs Authority – RFDA / Ministry of Health)
• Local pharmaceutical formulation & repackaging units
• Herbal & traditional medicine manufacturers
• Nutraceutical, food supplement & cosmetic producers
• Government, NGO & donor-supported supply programs
• Export to EAC countries, Central & East Africa, and humanitarian markets

Our BMR Services for Rwandan Manufacturers

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

✅ BMR Preparation

• Preparation of Rwanda-compliant and export-oriented BMRs aligned with:
o Rwanda FDA (RFDA) requirements
o WHO GMP Guidelines
o EAC regional regulatory expectations
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 raw 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 affecting RFDA registration or donor procurement
o Data-integrity and traceability risks
• Alignment with WHO and importing-country expectations

✅ Regulatory Query & Inspection Support

• Support for RFDA, Ministry of Health, 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 GMP standards
o EAC and 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, regional, and export market goals

Our Global Experience (Supporting Rwanda from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Strong experience supporting East African & emerging-market manufacturers
• Extensive work across:
o East & Central Africa
o West Africa
o South & Southeast Asia
• Exposure to:
o Essential medicines
o Herbal & traditional products
o Nutraceuticals & food supplements
• Regular interaction with:
o WHO
o National Medicines Regulatory Authorities
o Importing-country regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• Rwanda FDA (RFDA) requirements
• WHO GMP Guidelines
• EAC regulatory expectations
• 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 Rwanda

• 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 Rwandan Manufacturers Choose BMRx

• 🌍 Strong WHO & EAC-aligned documentation expertise
• 📋 Registration-, donor- & export-ready BMRs
• 🔍 Reduced regulatory, audit & inspection observations
• 🧠 Deep understanding of East African 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 / EAC / 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 Rwandan manufacturers for domestic, regional & global regulatory success