BMRx – Global Batch Manufacturing Record (BMR) Services for Cuba
CECMED–Aligned | WHO & EU GMP Compliant | Inspection-Ready
BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, delivering end-to-end Batch Manufacturing Record (BMR) Preparation & Review Services for pharmaceutical and regulated-industry manufacturers and MAHs supplying to the Cuban market and exporting to LATAM, Africa, Asia & global regulated markets.
Since 2008, BMRx has supported manufacturers across Cuba, Latin America, and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Center for State Control of Medicines, Equipment and Medical Devices (CECMED), Cuba, WHO GMP, EU GMP, and global inspection readiness.
Who We Serve in Cuba
We work with Cuba-based and Cuba-focused organizations involved in:
• Manufacturing for the Cuban domestic market (CECMED)
• Export to LATAM, Africa, Asia & international markets
• State-owned pharmaceutical & biotech organizations
• Contract manufacturing & technology transfer projects
• Scale-up & lifecycle management activities
• CECMED inspections, WHO audits & partner assessments
Our BMR Services for Cuba Market Products
✅ BMR Preparation
We prepare product-specific, process-driven BMRs aligned with:
• CECMED Cuba GMP requirements
• WHO GMP Guidelines
• EU GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• PIC/S GMP Requirements
Key Features
• Non-generic, site-specific BMRs
• Operator-friendly & shop-floor executable formats
• Clearly defined IPCs, CPPs, CQAs & yields
• Inspection-ready documentation acceptable to CECMED & global authorities
✅ BMR Review & GMP Compliance Check
Independent technical and GMP review of existing BMRs to identify:
• Missing CECMED / WHO GMP elements
• Documentation & data-integrity gaps
• Inspection-critical weaknesses
• Non-alignment with export-market expectations
Deliverables include clear, implementable remediation recommendations.
✅ Regulatory Query & Inspection Support
Support during:
• CECMED post-submission queries
• CECMED GMP inspections & follow-ups
• WHO audits & international partner inspections
• Export-market regulatory reviews
Including:
• Authority query responses
• Inspection observation remediation
• CAPA-linked BMR updates
✅ Gap Assessment & Remediation
Comprehensive gap analysis of existing BMRs against:
• CECMED Cuba GMP requirements
• WHO & EU GMP expectations
• PIC/S & export-market MOH requirements
With practical, floor-ready corrective actions suitable for Cuba-linked manufacturing environments.
✅ Customized BMR Templates
Provision of ready-to-use, regulator-accepted BMR templates, customized based on:
• Dosage form
• Equipment & batch size
• Manufacturing & packaging process
• Facility layout & utilities
• Target Cuba & export markets
Our Global Experience (Supporting Cuba from India)
• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Cuba
– Latin America
– Africa
– Asia
– Europe
– Middle East
Product Categories Supported
• Finished dosage forms
• APIs & intermediates
• Vaccines & biologics (documentation support)
• Sterile & non-sterile products
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
Regulatory Interaction Experience With
• CECMED Cuba
• WHO
• EU Authorities
• US FDA
• PIC/S Regulators
Regulatory Standards Followed
All BMR documentation is prepared in accordance with:
• CECMED Cuba GMP Guidelines
• WHO GMP
• EU GMP
• US FDA cGMP (21 CFR 210 & 211)
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)
Industries We Support in Cuba
• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Vaccines & Biologics (manufacturing documentation)
• Herbal & Traditional Products
• Nutraceuticals & Food Ingredients
• Cosmetics & Personal Care
Why Cuba Market Companies Choose BMRx
• 🇨🇺 Strong understanding of CECMED & WHO GMP expectations
• 🌍 Export-oriented BMRs accepted across LATAM & global markets
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced regulatory & international inspection observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven delivery
• 👷 Operator-friendly formats for reliable execution
How We Initiate a BMR Project
To initiate BMR preparation or review, we typically require:
• Product & formulation details
• Manufacturing / packaging process & flow diagram
• 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 Cuban manufacturers for LATAM, Africa, Asia & global regulatory success.