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

Hungary-Compliant | EU GMP Aligned | 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 Hungarian pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers supplying to EU and international regulated markets.

Since 2008, BMRx has supported manufacturers across Europe, North America, LATAM, Africa, Asia, and the Middle East with regulatory-compliant, authority-acceptable BMR documentation, ensuring smooth approvals, inspection readiness, and reduced regulatory observations.

Who We Serve in Hungary

We work with Hungary-based companies involved in:

• Manufacturing for the Hungarian & EU domestic market (OGYÉI – National Institute of Pharmacy and Nutrition)
• Export to EU, US, UK, Canada, ASEAN, GCC, Africa & LATAM
• API & intermediate manufacturing
• Finished dosage forms (OSD, injectables, liquids, semi-solids)
• Contract manufacturing (CMOs & CDMOs)
• Technology transfer & scale-up projects
• EU GMP, US FDA & WHO inspections

Our BMR Services for Hungarian Manufacturers

We provide complete lifecycle support for Batch Manufacturing Records, including:

✅ BMR Preparation

• Preparation of EU-compliant and export-oriented BMRs aligned with:
o EU GMP (EudraLex Volume 4)
o OGYÉI (Hungary) expectations
o US FDA (21 CFR Parts 210 & 211)
o WHO GMP
o PIC/S GMP
• Product-specific, process-driven, non-generic BMRs
• Clear documentation of CPPs, IPCs, yields, reconciliation, and deviations
• Operator-friendly, inspection-ready formats

✅ BMR Review & GMP Compliance Check

• Independent technical, GMP, and data-integrity review of existing BMRs
• Identification of:
o Missing EU GMP elements
o OGYÉI vs US FDA / WHO GMP gaps
o Data integrity and traceability risks
o Inspection-critical weaknesses
• Alignment with current EU and global regulatory expectations

✅ Regulatory Query & Inspection Support

• Support during OGYÉI, EU GMP, US FDA, and WHO inspections
• Handling of BMR-related authority queries:
o Pre-approval inspections
o Routine GMP audits
o For-cause inspections
• CAPA-linked BMR corrections and upgrades

✅ Gap Assessment & Remediation

• Detailed gap analysis of existing BMRs against:
o EU GMP vs US FDA / WHO GMP
o Export-market documentation expectations
• Practical, shop-floor-executable corrective actions
• Risk-based remediation for sterile, high-risk, and complex processes

✅ Customized BMR Templates

• Regulator-accepted, ready-to-use BMR templates
• Custom-built based on:
o Dosage form & manufacturing technology
o Equipment trains & batch size
o Facility layout & utilities
o EU and global export requirements

Our Global Experience (Supporting Hungary from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience supporting EU-to-US / WHO supply chains
• Strong exposure to:
o APIs & intermediates
o Oral solid dosage forms
o Injectables & sterile products
o Cosmetics & nutraceuticals
• Regular interaction with:
o EU Competent Authorities
o OGYÉI (Hungary)
o US FDA
o WHO / PIC/S regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• EU GMP (EudraLex Volume 4)
• OGYÉI GMP requirements (Hungary)
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10
• Import-country MOH and authority expectations

Industries We Support in Hungary

• Pharmaceuticals & APIs
• Finished Dosage Forms
• Injectables & Sterile Products
• Cosmetics & Personal Care
• Herbal & Natural Products
• Food & Nutraceutical Ingredients
• Chemicals & Industrial Products

Why Hungarian Manufacturers Choose BMRx

• 🇪🇺 Strong alignment with EU GMP & OGYÉI expectations
• 🌍 Export-oriented BMRs accepted globally
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced EU / US FDA GMP observations
• 🧠 Technical + GMP + regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional, and deadline-driven
• 👷 Operator-friendly formats for shop-floor execution

How We Start the Project

To initiate BMR preparation or review, we typically require:

• Product and formulation details
• Manufacturing process & flow diagram
• Equipment list and batch size
• Target export markets and regulatory strategy
• 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 Hungarian manufacturers for EU & global regulatory success