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

HSA–Aligned | PIC/S & WHO GMP Compliant | 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 pharmaceutical and regulated-industry manufacturers, MAHs, and contract facilities in Singapore supplying to domestic and international regulated markets.

Since 2008, BMRx has supported manufacturers across ASEAN and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with Health Sciences Authority (HSA) Singapore, PIC/S GMP, WHO GMP, and global inspection readiness.

Who We Serve in Singapore

We work with Singapore-based organizations involved in:

• Manufacturing for the Singapore domestic market (HSA)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Contract Manufacturing & Packaging Organizations (CMOs / CDMOs)
• Secondary manufacturing, packaging & labeling operations
• Technology transfer & site qualification projects
• HSA GMP inspections, PIC/S audits & customer audits

Our BMR Services for Singapore Companies

✅ BMR Preparation

We prepare product-specific, process-driven BMRs aligned with:

• HSA Singapore GMP requirements
• PIC/S GMP Guidelines
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines

Key Features:
• Facility-specific, non-generic BMRs
• Clear segregation of manufacturing, packaging & QC activities
• Operator-friendly & inspection-ready formats
• Fully traceable batch documentation acceptable to HSA & global authorities

✅ BMR Review & PIC/S GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing HSA / PIC/S GMP elements
• Data integrity & documentation gaps
• Inspection-critical weaknesses
• Gaps against export-market regulatory expectations

Deliverables include clear, actionable remediation recommendations.

✅ Regulatory Query & Inspection Support

Support during:

• HSA post-submission queries
• HSA GMP inspections & follow-ups
• PIC/S audits & customer inspections
• Cross-border regulatory reviews

Including:
• Authority query responses
• Inspection observation remediation
• CAPA-linked BMR corrections

✅ Gap Assessment & Remediation

Comprehensive gap analysis of existing BMRs against:

• HSA GMP requirements
• PIC/S & WHO GMP expectations
• Export-market MOH requirements

With practical, floor-ready corrective actions suitable for Singapore manufacturing and packaging environments.

✅ Customized BMR Templates

Provision of ready-to-use, regulator-accepted BMR templates, customized based on:

• Dosage form & packaging configuration
• Equipment & batch size
• Manufacturing / packaging / labeling process
• Facility layout & utilities
• Target domestic & export markets

Our Global Experience (Supporting Singapore from India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Singapore
– ASEAN
– India
– Middle East
– Africa
– Europe
– LATAM

Product Categories Supported:
• Finished dosage forms
• APIs & intermediates
• Cosmetics & personal care
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
• Chemicals & specialty products

Regulatory Interaction Experience With:
• Health Sciences Authority (HSA) – Singapore
• PIC/S Authorities
• WHO
• US FDA
• EU Authorities

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• HSA Singapore GMP Guidelines
• PIC/S GMP Requirements
• WHO GMP
• US FDA cGMP (21 CFR 210 & 211)
• EU GMP Guidelines
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)
• Country-specific MOH expectations for exports

Industries We Support in Singapore

• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Cosmetics & Personal Care
• Herbal & Traditional Medicines
• Nutraceuticals & Food Ingredients
• Industrial & Specialty Chemicals

Why Singapore Companies Choose BMRx

• 🇸🇬 Strong understanding of HSA & PIC/S GMP expectations
• 🌍 Export-oriented BMRs accepted globally
• 📋 Inspection-ready & auditable documentation
• 🔍 Reduced inspection observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven delivery
• 👷 Operator-friendly formats for seamless shop-floor execution

How We Initiate a BMR Project

To initiate BMR preparation or review, we typically require:

• Product & formulation details
• Manufacturing / packaging process & flow diagrams
• Equipment list & batch size
• Target markets & regulatory pathway
• 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 Singapore companies for global regulatory success