BMRx – Global Batch Manufacturing Record (BMR) Services for Mexico
COFEPRIS–Aligned | US FDA & WHO 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 Mexican market and exporting across North America, LATAM, and global regulated markets.
Since 2008, BMRx has supported manufacturers across Mexico, LATAM, the United States, and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), Mexico, WHO GMP, US FDA cGMP, and global inspection readiness.
Who We Serve in Mexico
We work with Mexico-based and Mexico-focused organizations involved in:
• Manufacturing for the Mexico domestic market (COFEPRIS)
• Export to US, LATAM, Canada & global markets
• Contract manufacturing (CMOs / CDMOs)
• Maquiladora & export-oriented manufacturing units
• Technology transfer & scale-up projects
• COFEPRIS inspections, US FDA audits & customer inspections
Our BMR Services for Mexico Market Products
✅ BMR Preparation
We prepare product-specific, process-driven BMRs aligned with:
• COFEPRIS GMP requirements (NOMs)
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• 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 COFEPRIS, US FDA & global authorities
✅ BMR Review & GMP Compliance Check
Independent technical and GMP review of existing BMRs to identify:
• Missing COFEPRIS / WHO / FDA GMP elements
• Documentation & data-integrity gaps
• Inspection-critical weaknesses
• Non-alignment with US & LATAM export-market expectations
Deliverables include clear, implementable remediation recommendations.
✅ Regulatory Query & Inspection Support
Support during:
• COFEPRIS post-submission queries
• COFEPRIS GMP inspections & follow-ups
• US FDA inspections & partner audits
• 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:
• COFEPRIS GMP & NOM requirements
• WHO & US FDA GMP expectations
• PIC/S & export-market MOH requirements
With practical, floor-ready corrective actions suitable for Mexico-based 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 Mexico, US & export markets
Our Global Experience (Supporting Mexico from India)
• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Mexico
– United States
– Latin America
– Europe
– Asia
– Africa
Product Categories Supported
• Finished dosage forms
• APIs & intermediates
• Sterile & injectable products
• Biologics & vaccines (documentation support)
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
Regulatory Interaction Experience With
• COFEPRIS – Mexico
• US FDA
• WHO
• EU Authorities
• PIC/S Regulators
Regulatory Standards Followed
All BMR documentation is prepared in accordance with:
• COFEPRIS GMP & NOM Guidelines
• WHO GMP
• US FDA cGMP (21 CFR 210 & 211)
• EU GMP
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)
Industries We Support in Mexico
• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Sterile & Injectable Manufacturing
• Biologics & Vaccines (manufacturing documentation)
• Herbal & Traditional Products
• Nutraceuticals & Food Ingredients
Why Mexico Market Companies Choose BMRx
• 🇲🇽 Strong understanding of COFEPRIS & US FDA GMP expectations
• 🌍 Export-oriented BMRs accepted in US, LATAM & global markets
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced COFEPRIS & FDA 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 Mexican manufacturers for US, LATAM & global regulatory success