BMRx – Global Batch Manufacturing Record (BMR) Services for Tunisia
Tunisia MOH–Aligned | EU & WHO GMP 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 serving the Tunisian market and exporting to regulated global markets.
Since 2008, BMRx has supported manufacturers across North Africa, MENA, Europe, and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Ministry of Health (MOH) – Tunisia / Directorate of Pharmacy and Medicines (DPM), WHO GMP, EU GMP, and global inspection readiness.
Who We Serve in Tunisia
We work with Tunisia-based and Tunisia-focused organizations involved in:
• Manufacturing for the Tunisian domestic market (MOH / DPM)
• Export to EU-linked, MENA, Africa & international markets
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer, scale-up & localization projects
• New manufacturing site approvals & license renewals
• MOH inspections, EU partner audits & customer inspections
Our BMR Services for Tunisia Manufacturers
✅ BMR Preparation
We prepare product-specific, process-driven BMRs aligned with:
• Tunisia MOH / DPM GMP requirements
• EU GMP Guidelines
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• PIC/S GMP Requirements
Key Features
• Non-generic, facility-specific BMRs
• Operator-friendly & shop-floor executable formats
• Clearly defined IPCs, CPPs & yields
• Inspection-ready documentation acceptable to MOH, EU partners & global authorities
✅ BMR Review & GMP Compliance Check
Independent technical and GMP review of existing BMRs to identify:
• Missing Tunisia MOH / EU GMP elements
• Documentation & data-integrity gaps
• Inspection-critical weaknesses
• Non-alignment with EU & export-market expectations
Deliverables include clear, implementable remediation recommendations.
✅ Regulatory Query & Inspection Support
Support during:
• Tunisia MOH post-submission queries
• MOH GMP inspections & follow-ups
• EU partner audits & customer inspections
• 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:
• Tunisia MOH / DPM GMP requirements
• EU & WHO GMP expectations
• PIC/S & export-market MOH requirements
With practical, floor-ready corrective actions suitable for Tunisian 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 Tunisia from India)
• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Tunisia
– North Africa & MENA
– Europe
– Asia
– LATAM
Product Categories Supported
• Finished dosage forms
• APIs & intermediates
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
• Cosmetics & personal care
• Chemicals & agrochemicals
Regulatory Interaction Experience
• Tunisia MOH / DPM
• WHO
• EU Authorities
• US FDA
• PIC/S Regulators
Regulatory Standards Followed
All BMR documentation is prepared in accordance with:
• Tunisia MOH / DPM GMP Guidelines
• EU GMP
• WHO GMP
• US FDA cGMP (21 CFR 210 & 211)
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)
• Country-specific MOH expectations for exports
Industries We Support in Tunisia
• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Herbal & Traditional Medicines
• Nutraceuticals & Food Ingredients
• Cosmetics & Personal Care
• Agrochemicals
• Industrial Chemicals
Why Tunisia Manufacturers Choose BMRx
• 🇹🇳 Strong understanding of Tunisia MOH & EU GMP expectations
• 🌍 Export-oriented BMRs accepted across EU & global markets
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced inspection & regulatory 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 Tunisian manufacturers for EU-linked, African & global regulatory success