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

Health Canada | US FDA | EU GMP | WHO | PIC/S Compliant
Inspection-Ready | Export-Focused | Globally Aligned

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, delivering end-to-end Batch Manufacturing Record (BMR) Preparation, Review, and Remediation Services for Canadian pharmaceutical and manufacturing companies supplying to domestic and international regulated markets.

Since 2008, BMRx has supported manufacturers worldwide with regulatory-compliant, authority-acceptable BMR documentation, helping ensure Health Canada compliance, seamless exports, inspection readiness, and reduced regulatory observations.

Who We Serve in Canada

We work with Canada-based organizations involved in:

• Manufacturing for the Canadian market (Health Canada)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Pharmaceutical CMOs & CDMOs
• API and finished dosage form manufacturers
• Technology transfer & scale-up projects
• New site, new product, or new line approvals
• Companies preparing for Health Canada, US FDA, EU GMP, WHO inspections

Our BMR Services for Canadian Manufacturers

✅ BMR Preparation

We develop country-specific, regulator-aligned BMRs compliant with:

• Health Canada GMP (GUI-0001 / Food and Drug Regulations)
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• WHO GMP
• PIC/S GMP Requirements

Key Features
• Product-specific, process-driven (non-generic) BMRs
• Operator-friendly execution formats
• Data-integrity-focused design
• Inspection-ready and audit-defensible documentation

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing GMP and compliance elements
• Data integrity and traceability gaps
• Inspection-critical weaknesses
• Misalignment with Health Canada and export market expectations

Outcome: Robust, compliant BMRs aligned with current global regulatory expectations.

✅ Regulatory Query & Inspection Support

Support for authority queries related to BMRs during:

• Health Canada inspections
• US FDA / EU GMP audits
• WHO or PIC/S inspections
• Post-inspection CAPA implementation

Includes BMR corrections, justifications, and regulator-acceptable responses.

✅ Gap Assessment & Remediation

• Comprehensive gap analysis of existing BMRs against:
– Health Canada GMP
– Updated global GMP guidelines
– Export country expectations
• Practical, shop-floor-ready corrective actions
• Alignment with quality systems and validation documentation

✅ Customized BMR Templates

• Ready-to-use, regulator-accepted BMR templates
• Customized based on:
– Dosage form
– Equipment and batch size
– Manufacturing process
– Facility layout and utilities
– Canadian and export regulatory pathways

Our Global Experience (Executed from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Experience across:
– North America
– Europe
– Asia
– Middle East
– Africa
– LATAM

Product Categories Covered
• APIs & intermediates
• Finished dosage forms
• Cosmetics & personal care
• Herbal & natural health products
• Food & nutraceutical ingredients
• Chemicals & agrochemicals

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• Health Canada GMP (GUI-0001)
• US FDA cGMP (21 CFR 210 & 211)
• EU GMP Guidelines
• WHO GMP
• PIC/S GMP Requirements
• ICH Q7, Q8, Q9, Q10 (where applicable)
• Country-specific MOH requirements for exports

Industries We Support in Canada

• Pharmaceuticals & APIs
• Natural Health Products (NHPs)
• Cosmetics & Personal Care
• Herbal & Botanical Products
• Food & Nutraceutical Ingredients
• Industrial & Specialty Chemicals

Why Canadian Manufacturers Choose BMRx

• 🌍 Globally aligned, export-ready BMRs
• 📋 Inspection-ready documentation accepted worldwide
• 🔍 Reduced GMP and data-integrity observations
• 🧠 Strong technical, GMP, and regulatory expertise
• 🛠️ Process-specific, non-generic BMRs
• 🔒 Confidential, professional, deadline-driven execution
• 👷 Operator-friendly records for real shop-floor use

How We Initiate the Project

To begin BMR preparation or review, we typically request:

• Product and formulation details
• Manufacturing process and flow diagrams
• Equipment list and batch size
• Target 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 Canadian manufacturers with globally acceptable BMR documentation.