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

EDA–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 Egypt supplying to domestic and international regulated markets.

Since 2008, BMRx has supported manufacturers across North Africa, the Middle East, and global export markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Egyptian Drug Authority (EDA), WHO GMP, PIC/S GMP, and global inspection readiness.

Who We Serve in Egypt

We work with Egypt-based organizations involved in:

• Manufacturing for the Egypt domestic market (EDA)
• Export to MENA, Africa, EU-linked, CIS & LATAM markets
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer, localization & expansion projects
• New manufacturing site approvals & EDA licensing
• EDA inspections, WHO audits & customer audits

Our BMR Services for Egypt Manufacturers

✅ BMR Preparation

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

• Egyptian Drug Authority (EDA) 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 EDA & global authorities

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing EDA / 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:

• EDA post-submission queries
• EDA 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:

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

With practical, floor-ready corrective actions suitable for Egyptian 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 domestic & export markets

Our Global Experience (Supporting Egypt from India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Egypt
– North & East Africa
– Middle East
– Asia
– 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:
• Egyptian Drug Authority (EDA)
• WHO
• US FDA
• EU Authorities
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• EDA GMP Guidelines – Egypt
• WHO GMP
• PIC/S GMP Requirements
• 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 Egypt

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

Why Egypt Manufacturers Choose BMRx

• 🇪🇬 Strong understanding of EDA & WHO GMP expectations
• 🌍 Export-oriented BMRs accepted across Africa & global markets
• 📋 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 / 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 Egyptian manufacturers for African, MENA & global regulatory success.