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

U GMP–Aligned | ANMDMR–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 Romanian market and the wider European Union.

Since 2008, BMRx has supported manufacturers across Europe and global regulated markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the National Agency for Medicines and Medical Devices of Romania (ANMDMR), EU GMP (EudraLex Volume 4), WHO GMP, and global inspection readiness.

Who We Serve in Romania

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

• Manufacturing for the Romanian domestic market (ANMDMR)
• Export to EU, EEA & global regulated markets
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer & scale-up projects
• New manufacturing site approvals, renewals & variations
• EU GMP inspections & partner audits

Our BMR Services for Romania Manufacturers

✅ BMR Preparation

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

• EU GMP Guidelines (EudraLex Volume 4)
• ANMDMR Romania GMP requirements
• 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 ANMDMR & EU inspectors

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing EU / ANMDMR 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:

• ANMDMR post-submission queries
• 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:

• EU GMP (EudraLex Volume 4)
• ANMDMR Romania expectations
• PIC/S & export-market requirements

With practical, floor-ready corrective actions suitable for EU-regulated 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 EU & international markets

Our Global Experience (Supporting Romania from India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Romania
– European Union & EEA
– CIS & Eurasia
– 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
• National Agency for Medicines and Medical Devices of Romania (ANMDMR)
• EU Authorities
• WHO
• US FDA
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

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

Industries We Support in Romania

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

Why Romania Market Companies Choose BMRx

• 🇷🇴 Strong understanding of EU & Romanian GMP expectations
• 🌍 Export-oriented BMRs accepted across the EU & globally
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced EU inspection & regulatory observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven delivery
• 👷 Operator-friendly formats for EU 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 Romanian manufacturers for EU, EEA & global regulatory success