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

BMRx – Africa Batch Manufacturing Record (BMR) Services

MOH-Compliant | Inspection-Ready | Trusted Across Africa

BMRx, a specialized scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Batch Manufacturing Record (BMR) Preparation and Review Services for African regulatory markets.

Since 2008, BMRx has been supporting pharmaceutical, cosmetic, herbal, and food manufacturers exporting to African countries, ensuring regulatory-compliant, authority-acceptable BMR documentation for product registrations, GMP inspections, and regulatory submissions.

Our services help manufacturers maintain clear, traceable, and regulator-ready manufacturing documentation, aligned with Ministry of Health (MOH) and National Medicines Regulatory Authority (NMRA) requirements across Africa.

What We Do

We provide complete lifecycle support for Batch Manufacturing Record documentation, including:

• Preparation of Batch Manufacturing Records (BMRs) according to African regulatory requirements

• Independent GMP and technical review of existing BMRs

• MOH / Regulatory Authority query response support related to BMR documentation

• Gap assessment of existing BMRs against current GMP standards

• Customization of BMRs based on dosage form, manufacturing process, equipment, and facility layout

• Provision of regulator-accepted BMR templates used in African regulatory submissions

All BMR documentation is developed with a process-driven and compliance-focused approach, ensuring traceability, operational clarity, and inspection readiness.

Our Africa Experience

• 3000+ BMRs prepared globally

• Supporting African market registrations since 2008

• Experience across East Africa, West Africa, North Africa, Central Africa, and Southern Africa

• Coverage of pharmaceuticals, APIs, cosmetics, food, herbal, and chemical products

• Strong exposure to MOH, National Medicines Regulatory Authorities (NMRAs), and regional regulators

• Proven success in new registrations, technology transfers, variations, GMP compliance, and renewals

Regulatory Standards Followed

Our BMR documentation aligns with international GMP standards accepted by African regulatory authorities, including:

• WHO GMP Guidelines

• PIC/S GMP Requirements

• US FDA cGMP (21 CFR Parts 210 & 211)

• EU GMP Guidelines

• ICH Q7 / Q8 / Q9 / Q10 (where applicable)

• Country-specific African MOH and NMRA GMP expectations

Industries We Serve

BMRx supports manufacturing documentation across multiple regulated industries supplying African markets:

• Pharmaceuticals & Active Pharmaceutical Ingredients (APIs)
• Cosmetics & Personal Care Products
• Herbal & Traditional Medicines
• Essential Oils & Fragrances
• Food Ingredients & Nutraceutical Products
• Agrochemicals
• Industrial Chemicals

Why Choose BMRx

• Regulatory-focused and non-generic BMR documentation

• Templates accepted across multiple African regulatory jurisdictions

• Strong experience supporting MOH inspections and queries

• Clear, auditable, and operator-friendly manufacturing records

• Reduced regulatory observations and documentation gaps

• Confidential, professional, and deadline-driven service

• Deep understanding of GMP manufacturing practices

How We Support You

To initiate BMR preparation or review, we typically require:

• Product and formulation details
• Manufacturing process and flow chart
• Equipment list and batch size
• Target African markets and regulatory pathway
• Existing BMR documentation (if available)

Based on this information, our team will provide a customized technical scope, project timeline, and commercial proposal.

BMRx

Batch Manufacturing Records. Built for Compliance. Ready for Inspection.

Supporting Manufacturers Across Africa. 🌍