BMRx – Global Batch Manufacturing Record (BMR) Services for Azerbaijan

Azerbaijan MOH–Aligned | WHO & EU 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 Azerbaijan market and regional exports.

Since 2008, BMRx has supported manufacturers across CIS, Eurasia, Middle East, and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Ministry of Health of the Republic of Azerbaijan / Analytical Expertise Center, WHO GMP, EU GMP, and global inspection readiness.

Who We Serve in Azerbaijan

We work with Azerbaijan-based and Azerbaijan-focused organizations involved in:

• Manufacturing for the Azerbaijan domestic market (MOH / AEC)
• Importation, local packaging & secondary manufacturing
• Export to CIS, Eurasian, Middle East & EU-linked markets
Contract manufacturing (CMOs / CDMOs)
Technology transfer & scale-up projects
MOH inspections, GMP audits & customer assessments

Our BMR Services for Azerbaijan Market Products

BMR Preparation

We prepare product-specific, process-driven BMRs aligned with:

Azerbaijan MOH GMP requirements
WHO GMP Guidelines
EU GMP Guidelines
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 MOH & international authorities

BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing Azerbaijan MOH / EU GMP elements
• Documentation & data-integrity gaps
• Inspection-critical weaknesses
• Non-alignment with CIS & export-market expectations

Deliverables include clear, implementable remediation recommendations.

Regulatory Query & Inspection Support

Support during:

Azerbaijan MOH post-submission queries
MOH GMP inspections & follow-ups
EU partner & customer audits
Export-market regulatory reviews

Including:
• Authority query responses
• Inspection observation remediation
CAPA-linked BMR corrections

Gap Assessment & Remediation

Comprehensive gap analysis of existing BMRs against:

• Azerbaijan MOH GMP requirements
• WHO & EU GMP expectations
• PIC/S & export-market MOH requirements

With practical, floor-ready corrective actions suitable for Azerbaijan-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 & export markets

Our Global Experience (Supporting Azerbaijan from India)

3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Azerbaijan
– CIS & Eurasia
– Middle East
– Asia
– Europe
– LATAM

Product Categories Supported
• Finished dosage forms
• APIs & intermediates
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
• Cosmetics & personal care
• Chemicals & specialty products

Regulatory Interaction Experience With
Azerbaijan Ministry of Health / Analytical Expertise Center
• WHO
• EU Authorities
• US FDA
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

Azerbaijan MOH GMP Guidelines
EU GMP
WHO GMP
US FDA cGMP (21 CFR 210 & 211)
PIC/S GMP Requirements
ICH Q7 / Q8 / Q9 / Q10 (where applicable)
Country-specific MOH expectations for exports

Industries We Support in Azerbaijan

• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Herbal & Traditional Medicines
• Nutraceuticals & Food Ingredients
• Cosmetics & Personal Care
• Industrial & Specialty Chemicals

Why Azerbaijan Market Companies Choose BMRx

• 🇦🇿 Strong understanding of Azerbaijan MOH & EU GMP expectations
• 🌍 Export-oriented BMRs accepted across CIS & 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 Azerbaijan market products for CIS, Eurasian & global regulatory success