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

Kuwait-Compliant | GCC 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 Kuwaiti pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers supplying to GCC and international regulated markets.

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

Who We Serve in Kuwait

We work with Kuwait-based companies involved in:

• Manufacturing for the Kuwaiti domestic market (Kuwait Ministry of Health – Drug & Food Control Administration)
• Export to GCC, US, EU, UK, Africa & LATAM
• Free-zone and industrial-area manufacturers
• Contract manufacturing (CMOs & CDMOs)
• Technology transfer & scale-up projects
• New manufacturing site approvals
• MOH, GCC & WHO inspections

Our BMR Services for Kuwaiti Manufacturers

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

✅ BMR Preparation

• Preparation of Kuwait-compliant and export-oriented BMRs aligned with:
o Kuwait MOH requirements
o GCC GMP Guidelines
o US FDA (21 CFR Parts 210 & 211)
o EU GMP (EudraLex Volume 4)
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 GMP elements
o Kuwait MOH vs US FDA / EU GMP gaps
o Data integrity and traceability risks
o Inspection-critical weaknesses
• Alignment with current GCC and global regulatory expectations

✅ Regulatory Query & Inspection Support

• Support during Kuwait MOH, GCC, US FDA, EU, 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 Kuwait / GCC GMP vs US FDA / EU 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 Kuwait, GCC, and global export requirements

Our Global Experience (Supporting Kuwait from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience supporting GCC-to-US / EU / WHO supply chains
• Strong exposure to:
o APIs & intermediates
o Finished dosage forms
o Injectables & sterile products
o Cosmetics & nutraceuticals
• Regular interaction with:
o Kuwait MOH
o GCC regulatory authorities
o US FDA
o EU authorities
o WHO / PIC/S regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

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

Industries We Support in Kuwait

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

Why Kuwaiti Manufacturers Choose BMRx

• 🇰🇼 Strong alignment with Kuwait MOH & GCC regulatory expectations
• 🌍 Export-oriented BMRs accepted globally
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced regulatory 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 Kuwaiti manufacturers for GCC & global regulatory success