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

EU GMP–Aligned | AEMPS–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 Spanish market and the wider European Union.

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

Who We Serve in Spain

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

• Manufacturing for the Spanish domestic market (AEMPS)
• 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 Spain Manufacturers

✅ BMR Preparation

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

• EU GMP Guidelines (EudraLex Volume 4)
• AEMPS Spain 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 AEMPS & EU inspectors

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing EU / AEMPS 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:

• AEMPS 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)
• AEMPS Spain 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 Spain from India)

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

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• EU GMP (EudraLex Volume 4)
• AEMPS Spain 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 Spain

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

Why Spain Market Companies Choose BMRx

• 🇪🇸 Strong understanding of EU & AEMPS 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 Spanish manufacturers for EU, EEA & global regulatory success.