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

BMRx – Asia Batch Manufacturing Record (BMR) Services

MOH-Compliant | Inspection-Ready | Trusted Across Asia

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

Since 2008, BMRx has been supporting pharmaceutical, cosmetic, herbal, and food manufacturers supplying products across Asian regulatory jurisdictions, ensuring regulatory-compliant, authority-acceptable BMR documentation for product registrations, GMP inspections, and manufacturing compliance.

Our services help manufacturers maintain clear, traceable, and regulator-ready manufacturing documentation aligned with country-specific Ministry of Health (MOH) expectations across Asia.

What We Do

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

• Preparation of Batch Manufacturing Records (BMRs) as per Asian country regulatory requirements

• Independent GMP and technical review of existing BMRs

• MOH query response support related to BMR documentation

• Gap assessment of existing BMRs against current GMP expectations

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

• Provision of regulator-accepted BMR templates used across Asian regulatory submissions

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

Our Asia Experience

• 3000+ BMRs prepared globally

• Supporting Asian manufacturers and exporters since 2008

• Extensive experience across South Asia, Southeast Asia, East Asia, and Central Asia

• Expertise covering pharmaceuticals, APIs, cosmetics, food, herbal, and chemical products

• Strong regulatory exposure to Ministry of Health (MOH) authorities across Asia

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

Regulatory Standards Followed

Our BMR documentation aligns with international GMP principles and Asian regulatory expectations, 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 Asian MOH GMP requirements

Industries We Serve

BMRx supports manufacturing documentation across multiple regulated industries in Asia:

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

Why Choose BMRx

• Regulatory-focused, non-generic BMR documentation

• Templates compatible with Asian regulatory submissions

• Strong experience supporting MOH inspections

• Clear, auditable, and operator-friendly manufacturing records

• Reduced regulatory observations and documentation gaps

• Confidential, professional, and deadline-driven service

• Deep understanding of manufacturing floor and GMP operations

How We Support You

To initiate BMR preparation or technical review, we typically require the following information:

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

Based on the provided information, our team will issue a customized technical scope, project timeline, and commercial proposal.

BMRx

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

Supporting Manufacturers Across Asia.