BMRx – Global Batch Manufacturing Record (BMR) Services for Peru
DIGEMID–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 Peruvian market and exporting across Andean, LATAM & global regulated markets.
Since 2008, BMRx has supported manufacturers across Peru, Latin America, and international markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), Peru, WHO GMP, EU GMP, and global inspection readiness.
Who We Serve in Peru
We work with Peru-based and Peru-focused organizations involved in:
• Manufacturing for the Peru domestic market (DIGEMID)
• Export to Andean Community, LATAM & international markets
• Public & private pharmaceutical manufacturers
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer & scale-up projects
• DIGEMID inspections, WHO audits & customer inspections
Our BMR Services for Peru Market Products
✅ BMR Preparation
We prepare product-specific, process-driven BMRs aligned with:
• DIGEMID Peru 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 DIGEMID & international authorities
✅ BMR Review & GMP Compliance Check
Independent technical and GMP review of existing BMRs to identify:
• Missing DIGEMID / 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:
• DIGEMID post-submission queries
• DIGEMID 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:
• DIGEMID Peru GMP requirements
• WHO & EU GMP expectations
• PIC/S & export-market MOH requirements
With practical, floor-ready corrective actions suitable for Peru-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 Peru & export markets
Our Global Experience (Supporting Peru from India)
• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Peru
– Andean Community
– Latin America
– United States
– Europe
– Asia
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
• DIGEMID Peru
• WHO
• EU Authorities
• US FDA
• PIC/S Regulators
Regulatory Standards Followed
All BMR documentation is prepared in accordance with:
• DIGEMID Peru 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 Peru
• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Sterile & Injectable Manufacturing
• Vaccines & Biologics (manufacturing documentation)
• Herbal & Traditional Products
• Nutraceuticals & Food Ingredients
Why Peru Market Companies Choose BMRx
• 🇵🇪 Strong understanding of DIGEMID & 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 Peruvian manufacturers for Andean, LATAM & global regulatory success.