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

Portugal-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 Portuguese pharmaceutical, API, biotech-support, 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 Portugal

We work with Portugal-based companies involved in:

• Manufacturing for the Portuguese & EU domestic market (INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde)
• Export to EU, US, UK, Canada, ASEAN, GCC, Africa & LATAM
• API & intermediate manufacturing
• Finished dosage forms (OSD, injectables, sterile products, liquids, semi-solids)
• Contract manufacturing (CMOs & CDMOs)
• Technology transfer & scale-up projects
• EU GMP, US FDA & WHO inspections

Our BMR Services for Portuguese 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 INFARMED (Portugal) requirements
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, critical quality attributes, 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 INFARMED 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 INFARMED, 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, biotech, and high-risk 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 & automation
o EU and global export requirements

Our Global Experience (Supporting Portugal 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 Biopharma-support and high-compliance facilities
• Regular interaction with:
o EU Competent Authorities
o INFARMED (Portugal)
o US FDA
o WHO / PIC/S regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• EU GMP (EudraLex Volume 4)
• INFARMED GMP requirements (Portugal)
• 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 Portugal

• Pharmaceuticals & APIs
• Finished Dosage Forms
• Injectables & Sterile Products
• Biopharma & Advanced Therapies (documentation support)
• Cosmetics & Personal Care
• Herbal & Natural Products
• Food & Nutraceutical Ingredients
• Chemicals & Industrial Products

Why Portuguese Manufacturers Choose BMRx

• 🇵🇹 Strong alignment with EU GMP & INFARMED 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 Portuguese manufacturers for EU & global regulatory success