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

AMDM–Aligned | EU & WHO GMP Compliant | Inspection-Ready

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, delivering end-to-end Batch Manufacturing Record (BMR) Preparation & Review Services for pharmaceutical and regulated-industry manufacturers and MAHs supplying to the Moldovan 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 Medicines and Medical Devices Agency of Moldova (AMDM), EU-aligned GMP requirements, WHO GMP, and global inspection readiness.

Who We Serve in Moldova

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

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

Our BMR Services for Moldova Manufacturers

✅ BMR Preparation

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

• AMDM Moldova GMP requirements
• EU-aligned GMP (EudraLex Volume 4 – as applicable)
• 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 AMDM & EU-linked inspectors

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing AMDM / EU-aligned 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:

• AMDM post-submission queries
• AMDM & EU-aligned 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:

• AMDM Moldova GMP requirements
• EU-aligned GMP expectations
• PIC/S & export-market requirements

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 Moldova, EU & export markets

Our Global Experience (Supporting Moldova from India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Moldova
– 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
• Medicines and Medical Devices Agency of Moldova (AMDM)
• EU Authorities
• WHO
• US FDA
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• AMDM Moldova GMP Guidelines
• EU-aligned GMP (EudraLex Volume 4 – as applicable)
• WHO GMP
• US FDA cGMP (21 CFR 210 & 211)
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)

Industries We Support in Moldova

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

Why Moldova Market Companies Choose BMRx

• 🇲🇩 Strong understanding of AMDM & EU-aligned GMP expectations
• 🌍 Export-oriented BMRs accepted across EU & global markets
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced regulatory & EU-aligned 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 Moldovan manufacturers for EU, Eastern European & global regulatory success