BMRx – Global Batch Manufacturing Record (BMR) Services for Ecuador
ARCSA–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 Ecuadorian market and exporting across Latin America and global regulated markets.
Since 2008, BMRx has supported manufacturers across Ecuador, LATAM, and international markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA), Ecuador, WHO GMP, EU GMP, and global inspection readiness.
Who We Serve in Ecuador
We work with Ecuador-based and Ecuador-focused organizations involved in:
• Manufacturing for the Ecuador domestic market (ARCSA)
• Export to LATAM, Andean Community & international markets
• Public & private pharmaceutical manufacturers
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer & scale-up projects
• ARCSA inspections, WHO audits & customer inspections
Our BMR Services for Ecuador Market Products
✅ BMR Preparation
We prepare product-specific, process-driven BMRs aligned with:
• ARCSA Ecuador 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 ARCSA & international authorities
✅ BMR Review & GMP Compliance Check
Independent technical and GMP review of existing BMRs to identify:
• Missing ARCSA / WHO GMP elements
• Documentation & data-integrity gaps
• Inspection-critical weaknesses
• Non-alignment with Andean & export-market expectations
Deliverables include clear, implementable remediation recommendations.
✅ Regulatory Query & Inspection Support
Support during:
• ARCSA post-submission queries
• ARCSA GMP inspections & follow-ups
• WHO audits & 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:
• ARCSA Ecuador GMP requirements
• WHO & EU GMP expectations
• PIC/S & export-market MOH requirements
With practical, floor-ready corrective actions suitable for Ecuador-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 Ecuador & export markets
Our Global Experience (Supporting Ecuador from India)
• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Ecuador
– Latin America
– United States
– Europe
– Asia
– Africa
Product Categories Supported
• Finished dosage forms
• APIs & intermediates
• Sterile & injectable products
• Vaccines & biologics (documentation support)
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
Regulatory Interaction Experience With
• ARCSA Ecuador
• WHO
• EU Authorities
• US FDA
• PIC/S Regulators
Regulatory Standards Followed
All BMR documentation is prepared in accordance with:
• ARCSA Ecuador 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 Ecuador
• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Sterile & Injectable Manufacturing
• Vaccines & Biologics (manufacturing documentation)
• Herbal & Traditional Products
• Nutraceuticals & Food Ingredients
Why Ecuador Market Companies Choose BMRx
• 🇪🇨 Strong understanding of ARCSA & 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 Ecuadorian manufacturers for Andean, LATAM & global regulatory success