BMRx – Global Batch Manufacturing Record (BMR) Services for Russia
Russia MOH–Aligned | EAEU & WHO GMP Compliant | Inspection-Ready
BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Batch Manufacturing Record (BMR) Preparation & Review Services for pharmaceutical and regulated-industry manufacturers and MAHs supplying to the Russian Federation market and the wider Eurasian Economic Union (EAEU).
Since 2008, BMRx has supported manufacturers across Russia, EAEU, CIS, Europe, and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Ministry of Health of the Russian Federation (Minzdrav Russia), Roszdravnadzor inspection expectations, EAEU GMP, WHO GMP, and global inspection readiness.
Who We Serve in Russia
We work with Russia-based and Russia-focused organizations involved in:
• Manufacturing for the Russian domestic market (Minzdrav / Roszdravnadzor)
• Export to EAEU markets (Kazakhstan, Belarus, Armenia, Kyrgyzstan)
• Importation, local packaging & secondary manufacturing
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer & localization projects
• MOH & EAEU GMP inspections and partner audits
Our BMR Services for Russia Market Products
✅ BMR Preparation
We prepare product-specific, process-driven BMRs aligned with:
• Russian MOH / Roszdravnadzor GMP requirements
• EAEU GMP Rules
• WHO GMP Guidelines
• EU GMP Guidelines (where applicable)
• US FDA cGMP (21 CFR Parts 210 & 211)
• PIC/S GMP Requirements
Key Features
• Non-generic, facility-specific BMRs
• Operator-friendly & shop-floor executable formats
• Clearly defined IPCs, CPPs & yields
• Inspection-ready documentation acceptable to Russian & EAEU inspectors
✅ BMR Review & GMP Compliance Check
Independent technical and GMP review of existing BMRs to identify:
• Missing Russian MOH / EAEU GMP elements
• Documentation & data-integrity gaps
• Inspection-critical weaknesses
• Non-alignment with EAEU & export-market expectations
Deliverables include clear, implementable remediation recommendations.
✅ Regulatory Query & Inspection Support
Support during:
• Russian MOH / Roszdravnadzor post-submission queries
• MOH & EAEU GMP inspections & follow-ups
• Partner, distributor & customer 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:
• Russian MOH GMP requirements
• EAEU & WHO GMP expectations
• PIC/S & export-market MOH requirements
With practical, floor-ready corrective actions suitable for Russia-linked 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 domestic & EAEU export markets
Our Global Experience (Supporting Russia from India)
• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Russia
– EAEU & CIS countries
– Europe
– Middle East
– Asia
– LATAM
Product Categories Supported
• Finished dosage forms
• APIs & intermediates
• Sterile & non-sterile products
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
• Cosmetics & personal care
Regulatory Interaction Experience With
• Ministry of Health of the Russian Federation (Minzdrav)
• Roszdravnadzor
• EAEU Regulatory Authorities
• WHO
• EU Authorities
• US FDA
• PIC/S Regulators
Regulatory Standards Followed
All BMR documentation is prepared in accordance with:
• Russian MOH / Roszdravnadzor GMP Guidelines
• EAEU GMP Rules
• WHO GMP
• EU GMP (where applicable)
• US FDA cGMP (21 CFR 210 & 211)
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)
• Country-specific MOH requirements for exports
Industries We Support in Russia
• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Sterile & Injectable Products
• Herbal & Traditional Medicines
• Nutraceuticals & Food Ingredients
• Cosmetics & Personal Care
• Industrial & Specialty Chemicals
Why Russia Market Companies Choose BMRx
• 🇷🇺 Strong understanding of Russian MOH & EAEU GMP expectations
• 🌍 Export-oriented BMRs accepted across EAEU & global markets
• 📋 Inspection-ready & auditable documentation
• 🔍 Reduced regulatory & inspection observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven delivery
• 👷 Operator-friendly formats for shop-floor 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 Russian manufacturers for EAEU, CIS & global regulatory success.