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

China-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 Chinese pharmaceutical, API, formulation, cosmetic, herbal, food, and chemical manufacturers supplying to domestic and international regulated markets.

Since 2008, BMRx has supported manufacturers across China, Asia, Europe, North America, LATAM, Africa, and the Middle East with regulatory-compliant, authority-acceptable BMR documentation, enabling smooth approvals, successful inspections, and reduced regulatory observations.

Who We Serve in China

We work with China-based companies involved in:

• Manufacturing for the Chinese domestic market (NMPA)
• Export to US, EU, UK, Japan, ASEAN, GCC, Africa & LATAM
• API & intermediate manufacturing
• Finished dosage forms (OSD, injectables, biologics support, semi-solids)
• Contract manufacturing (CMOs & CDMOs)
• Technology transfer and global scale-up projects
• US FDA / EU / WHO inspections and audits

Our BMR Services for Chinese Manufacturers

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

✅ BMR Preparation

• Preparation of country-specific and export-oriented BMRs aligned with:
o NMPA GMP (China)
o US FDA (21 CFR Parts 210 & 211)
o EU GMP
o WHO GMP
o PIC/S GMP
• Product-specific, process-driven, non-generic BMRs
• Clear documentation of CPPs, IPCs, critical quality attributes, yields, and reconciliation
• Operator-friendly, bilingual-ready formats (English-focused for exports)

✅ BMR Review & GMP Compliance Check

• Independent technical, GMP, and data-integrity review of existing BMRs
• Identification of:
o Missing GMP elements
o NMPA vs US FDA / EU GMP gaps
o Data integrity and traceability risks
o Inspection-critical weaknesses
• Alignment with current global regulatory and inspection expectations

✅ Regulatory Query & Inspection Support

• Support for NMPA, US FDA, EU, and WHO inspections
• Handling of BMR-related authority queries:
o Pre-approval inspections
o Routine GMP audits
o For-cause inspections
• CAPA-linked BMR corrections and upgrades

✅ Gap Assessment & Remediation

• Detailed gap analysis of existing BMRs against:
o NMPA GMP vs US FDA / EU GMP
o Export-market documentation expectations
• Practical, shop-floor-executable corrective actions
• Risk-based remediation for high-volume APIs, injectables, and critical processes

✅ Customized BMR Templates

• Regulator-accepted, ready-to-use BMR templates
• Custom-built based on:
o Dosage form and process technology
o Equipment trains and batch size
o Facility layout, utilities, and automation level
o Domestic and export market requirements

Our Global Experience (Supporting China from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience supporting China-to-US / EU / WHO supply chains
• Strong exposure to:
o APIs & intermediates
o Oral solid dosage forms
o Sterile & injectable products
o Specialty chemicals and excipients
• Regular interaction with:
o NMPA-aligned inspection teams
o US FDA
o EU authorities
o WHO / PIC/S regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• NMPA GMP (China)
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10
• Importing-country MOH and authority expectations

Industries We Support in China

• APIs & Intermediates
• Finished Dosage Forms
• Injectables & Sterile Products
• Biopharma Support (small molecules & intermediates)
• Cosmetics & Personal Care
• Herbal & Traditional Medicine Products
• Food & Nutraceutical Ingredients
• Industrial & Specialty Chemicals

Why Chinese Manufacturers Choose BMRx

• 🌍 Export-oriented BMRs accepted by US FDA, EU & WHO
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced US FDA / EU GMP observations
• 🧠 Strong understanding of NMPA vs global GMP gaps
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional, and deadline-driven
• 👷 Operator-friendly documentation for complex operations

How We Start the Project

To initiate BMR preparation or review, we typically require:

• Product and formulation details
• Manufacturing process & flow diagram
• Equipment list and batch size
• Target export markets and regulatory strategy
• 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 Chinese manufacturers for global regulatory success.