BMRx – Global Batch Manufacturing Record (BMR) Services for Saudi Arabia

SFDA–Aligned | WHO & PIC/S GMP Compliant | 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 pharmaceutical and regulated-industry manufacturers and MAHs in Saudi Arabia supplying to domestic and international regulated markets.

Since 2008, BMRx has supported manufacturers across the GCC and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with Saudi Food & Drug Authority (SFDA) requirements, WHO GMP, PIC/S GMP, and global inspection readiness.

Who We Serve in Saudi Arabia

We work with Saudi Arabia–based organizations involved in:

• Manufacturing for the Saudi domestic market (SFDA)
• Export to GCC, MENA, Africa, EU & other regulated markets
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer, localization & Vision 2030 projects
• New manufacturing site approvals & SFDA licensing
• SFDA inspections, WHO audits & customer audits

Our BMR Services for Saudi Manufacturers

✅ BMR Preparation

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

• SFDA GMP requirements
• WHO GMP Guidelines
• PIC/S GMP Requirements
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines

Key Features:
• Non-generic, facility-specific BMRs
• Operator-friendly & shop-floor executable formats
• Clear in-process controls, yields & critical parameters
• Inspection-ready documentation acceptable to SFDA & global authorities

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing SFDA / PIC/S GMP elements
• Data integrity & documentation gaps
• Inspection-critical weaknesses
• Non-alignment with export-market expectations

Deliverables include clear, implementable remediation recommendations.

✅ Regulatory Query & Inspection Support

Support during:

• SFDA post-submission queries
• SFDA GMP inspections & follow-ups
• WHO audits & customer inspections
• Export-market regulatory reviews

Including:
• Authority query responses
• Inspection observation remediation
• CAPA-linked BMR corrections

✅ Gap Assessment & Remediation

Comprehensive gap analysis of existing BMRs against:

• SFDA GMP requirements
• WHO & PIC/S GMP expectations
• Export-market MOH requirements

With practical, floor-ready corrective actions suitable for Saudi manufacturing environments.

✅ Customized BMR Templates

Provision of ready-to-use, regulator-accepted BMR templates, customized based on:

• Dosage form
• Equipment & batch size
• Manufacturing process
• Facility layout & utilities
• Target domestic & export markets

Our Global Experience (Supporting Saudi Arabia from India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Saudi Arabia
– GCC
– Middle East
– Asia
– Africa
– Europe
– LATAM

Product Categories Supported:
• Finished dosage forms
• APIs & intermediates
• Cosmetics & personal care
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
• Chemicals & agrochemicals

Regulatory Interaction Experience With:
• Saudi Food & Drug Authority (SFDA)
• WHO
• US FDA
• EU Authorities
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• SFDA GMP Guidelines
• PIC/S GMP Requirements
• WHO GMP
• US FDA cGMP (21 CFR 210 & 211)
• EU GMP Guidelines
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)
• Country-specific MOH expectations for exports

Industries We Support in Saudi Arabia

• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Herbal & Traditional Medicines
• Nutraceuticals & Food Ingredients
• Cosmetics & Personal Care
• Agrochemicals
• Industrial Chemicals

Why Saudi Manufacturers Choose BMRx

• 🇸🇦 Strong understanding of SFDA & PIC/S GMP expectations
• 🌍 Export-oriented BMRs accepted globally
• 📋 Inspection-ready & auditable documentation
• 🔍 Reduced inspection observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven delivery
• 👷 Operator-friendly formats for shop-floor execution

How We Initiate a BMR Project

To initiate BMR preparation or review, we typically require:

• Product & formulation details
• Manufacturing 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 Saudi manufacturers for GCC and global regulatory success