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

Kyrgyzstan 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 Kyrgyzstan market and the wider Eurasian Economic Union (EAEU).

Since 2008, BMRx has supported manufacturers across Central Asia, EAEU, CIS, Europe, and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Ministry of Health of the Kyrgyz Republic / Department of Medicines and Medical Devices, EAEU GMP, WHO GMP, and global inspection readiness.

Who We Serve in Kyrgyzstan

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

• Manufacturing for the Kyrgyzstan domestic market (MOH)
• Export to EAEU markets (Russia, Kazakhstan, Belarus, Armenia)
• Importation, local packaging & secondary manufacturing
Contract manufacturing (CMOs / CDMOs)
Technology transfer & localization projects
MOH & EAEU GMP inspections and partner audits

Our BMR Services for Kyrgyzstan Market Products

BMR Preparation

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

Kyrgyzstan MOH 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 Kyrgyz MOH & EAEU inspectors

BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing Kyrgyzstan 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:

Kyrgyzstan MOH 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:

• Kyrgyzstan MOH GMP requirements
• EAEU & WHO GMP expectations
• PIC/S & export-market MOH requirements

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

3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Kyrgyzstan
– Central Asia & 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
Kyrgyzstan Ministry of Health / Medicines Authorities
• EAEU Regulatory Authorities
• WHO
• EU Authorities
• US FDA
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

Kyrgyzstan MOH 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 Kyrgyzstan

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

Why Kyrgyzstan Market Companies Choose BMRx

• 🇰🇬 Strong understanding of Kyrgyzstan 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 Kyrgyzstan manufacturers for EAEU, Central Asian & global regulatory success