BMRx – Global Batch Manufacturing Record (BMR) Services for Costa Rica
Costa Rica 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 Costa Rican market and exporting to Latin America, the United States, and other regulated markets.
Since 2008, BMRx has supported manufacturers across LATAM, North America, and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Ministry of Health of Costa Rica (Ministerio de Salud), WHO GMP, US FDA cGMP, and global inspection readiness.
Who We Serve in Costa Rica
We work with Costa Rica–based and Costa Rica–focused organizations involved in:
• Manufacturing for the Costa Rica domestic market (MOH)
• Export to Central America, LATAM, US & global markets
• Contract manufacturing (CMOs / CDMOs)
• Medical device & pharma manufacturing clusters
• Technology transfer & scale-up projects
• MOH inspections, US FDA audits & customer inspections
Our BMR Services for Costa Rica Market Products
✅ BMR Preparation
We prepare product-specific, process-driven BMRs aligned with:
• Costa Rica MOH 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 MOH, US FDA & global authorities
✅ BMR Review & GMP Compliance Check
Independent technical and GMP review of existing BMRs to identify:
• Missing Costa Rica MOH / 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:
• Costa Rica MOH post-submission queries
• MOH 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:
• Costa Rica MOH GMP requirements
• WHO & US FDA GMP expectations
• PIC/S & export-market MOH requirements
With practical, floor-ready corrective actions suitable for Costa Rica–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 Costa Rica, US & LATAM export markets
Our Global Experience (Supporting Costa Rica from India)
• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Costa Rica
– Central America & LATAM
– United States
– Europe
– Asia
– Africa
Product Categories Supported
• Finished dosage forms
• APIs & intermediates
• Sterile & injectable products
• Medical device–related pharma products
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
Regulatory Interaction Experience With
• Ministry of Health – Costa Rica
• US FDA
• WHO
• EU Authorities
• PIC/S Regulators
Regulatory Standards Followed
All BMR documentation is prepared in accordance with:
• Costa Rica MOH 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 Costa Rica
• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Sterile & Injectable Manufacturing
• Medical Device–Linked Pharmaceuticals
• Nutraceuticals & Food Ingredients
• Cosmetics & Personal Care
Why Costa Rica Market Companies Choose BMRx
• 🇨🇷 Strong understanding of Costa Rica MOH & US FDA GMP expectations
• 🌍 Export-oriented BMRs accepted across LATAM & 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 Costa Rican manufacturers for LATAM, US & global regulatory success.