Ukraine

Ukraine MOH–Aligned | EU & 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 Ukrainian market and exporting to regulated international markets.

Since 2008, BMRx has supported manufacturers across Eastern Europe, CIS, EU-linked, and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Ministry of Health of Ukraine (MOH), State Expert Center of the MOH of Ukraine (SEC), EU GMP, WHO GMP, and global inspection readiness.

Who We Serve in Ukraine

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

• Manufacturing for the Ukraine domestic market (MOH / SEC)
• Export to EU, Eastern Europe, CIS & global markets
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer, localization & scale-up projects
• New manufacturing site approvals & variations
• MOH / EU GMP inspections & partner audits

Our BMR Services for Ukraine Manufacturers

✅ BMR Preparation

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

• Ukraine MOH / SEC GMP requirements
• EU GMP Guidelines (EudraLex Volume 4)
• WHO 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 Ukrainian & EU inspectors

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing Ukraine MOH / EU GMP elements
• Data integrity (ALCOA+) gaps
• Inspection-critical weaknesses
• Non-alignment with current EU GMP expectations

Deliverables include clear, implementable remediation recommendations.

✅ Regulatory Query & Inspection Support

Support during:

• Ukraine MOH / SEC post-submission queries
• MOH & EU GMP inspections & follow-ups
• Partner & 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:

• Ukraine MOH / SEC GMP requirements
• EU GMP (EudraLex Vol. 4)
• WHO GMP & PIC/S expectations

With practical, floor-ready corrective actions suitable for EU-aligned 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 Ukraine, EU & export markets

Our Global Experience (Supporting Ukraine from India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Ukraine
– Eastern Europe
– European Union
– CIS
– Middle East
– Asia
– LATAM

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

Regulatory Interaction Experience With
• Ministry of Health of Ukraine
• State Expert Center (SEC), Ukraine
• EU Authorities
• WHO
• US FDA
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• Ukraine MOH / SEC GMP Guidelines
• EU GMP (EudraLex Volume 4)
• WHO GMP
• US FDA cGMP (21 CFR 210 & 211)
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)

Industries We Support in Ukraine

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

Why Ukraine Market Companies Choose BMRx

• 🇺🇦 Strong understanding of Ukraine MOH & EU GMP expectations
• 🌍 Export-oriented BMRs accepted across EU & global markets
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced regulatory & EU inspection observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven delivery
• 👷 Operator-friendly formats for EU-aligned 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 Ukrainian manufacturers for EU, Eastern European & global regulatory success