Guatemala
Guatemala MOH–Aligned | WHO & US FDA 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 Guatemalan market and exporting to Central America, LATAM, the United States, and global regulated markets.
Since 2008, BMRx has supported manufacturers across Central America, LATAM, North America, and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Ministry of Public Health and Social Assistance (MSPAS), Guatemala, WHO GMP, US FDA cGMP, and global inspection readiness.
Who We Serve in Guatemala
We work with Guatemala-based and Guatemala-focused organizations involved in:
• Manufacturing for the Guatemala domestic market (MSPAS)
• Export to Central America, LATAM & international markets
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer & scale-up projects
• Local packaging, secondary manufacturing & repacking
• MSPAS inspections, US FDA audits & customer inspections
Our BMR Services for Guatemala Market Products
✅ BMR Preparation
We prepare product-specific, process-driven BMRs aligned with:
• Guatemala MSPAS GMP requirements
• 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 MSPAS, US FDA & global authorities
✅ BMR Review & GMP Compliance Check
Independent technical and GMP review of existing BMRs to identify:
• Missing MSPAS / WHO / FDA GMP elements
• Documentation & data-integrity gaps
• Inspection-critical weaknesses
• Non-alignment with Central America & export-market expectations
Deliverables include clear, implementable remediation recommendations.
✅ Regulatory Query & Inspection Support
Support during:
• Guatemala MSPAS post-submission queries
• MSPAS 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:
• Guatemala MSPAS GMP requirements
• WHO & US FDA GMP expectations
• PIC/S & export-market MOH requirements
With practical, floor-ready corrective actions suitable for Guatemala-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 Guatemala, Central America & export markets
Our Global Experience (Supporting Guatemala from India)
• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Guatemala
– Central America
– Latin America
– United States
– Europe
– Asia
Product Categories Supported
• Finished dosage forms
• APIs & intermediates
• Sterile & injectable products
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
• Cosmetics & personal care
Regulatory Interaction Experience With
• Ministry of Public Health and Social Assistance (MSPAS), Guatemala
• US FDA
• WHO
• EU Authorities
• PIC/S Regulators
Regulatory Standards Followed
All BMR documentation is prepared in accordance with:
• Guatemala MSPAS GMP 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 Guatemala
• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Sterile & Injectable Manufacturing
• Herbal & Traditional Products
• Nutraceuticals & Food Ingredients
• Cosmetics & Personal Care
Why Guatemala Market Companies Choose BMRx
• 🇬🇹 Strong understanding of Guatemala MSPAS & US FDA GMP expectations
• 🌍 Export-oriented BMRs accepted across Central America & global markets
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced MOH & 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 Guatemalan manufacturers for Central America, LATAM & global regulatory success.