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

Georgia 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 Georgian market and regional exports.

Since 2008, BMRx has supported manufacturers across Caucasus, CIS, Europe, and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia (MoLHSA) and the LEPL Agency of State Regulation of Medical Activities (ASRMA), WHO GMP, EU GMP, and global inspection readiness.

Who We Serve in Georgia

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

• Manufacturing for the Georgia domestic market (MoLHSA / ASRMA)
• Importation, local packaging & secondary manufacturing
• Export to Caucasus, CIS, EU-linked & international markets
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer & scale-up projects
• MOH GMP inspections & partner audits

Our BMR Services for Georgia Market Products

✅ BMR Preparation

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

• Georgia MOH / ASRMA 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 Georgian & international authorities

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing Georgia 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:

• Georgia MOH / ASRMA 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:

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

With practical, floor-ready corrective actions suitable for Georgian 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 Georgia from India)

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

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

Regulatory Interaction Experience With
• Georgia MoLHSA / ASRMA
• WHO
• EU Authorities
• US FDA
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• Georgia MOH / ASRMA 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 Georgia

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

Why Georgia Market Companies Choose BMRx

• 🇬🇪 Strong understanding of Georgia MOH & EU GMP expectations
• 🌍 Export-oriented BMRs accepted across Caucasus & 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 Georgian manufacturers for Caucasus, CIS, EU-linked & global regulatory success