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

Morocco-Compliant | EU & Global 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 Moroccan pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers supplying to domestic, African, EU, and international regulated markets.

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

Who We Serve in Morocco

We work with Morocco-based companies involved in:

• Manufacturing for the Morocco domestic market
(Ministry of Health & Social Protection – Directorate of Medicines and Pharmacy (DMP))
• Export to EU, US, UK, Africa, GCC & LATAM
• API & intermediate manufacturing
• Finished dosage forms (OSD, injectables, sterile products, liquids, semi-solids)
• Contract manufacturing (CMOs & CDMOs)
• Technology transfer & scale-up projects
• DMP, EU GMP & WHO inspections

Our BMR Services for Moroccan Manufacturers

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

✅ BMR Preparation

• Preparation of Morocco-compliant and export-oriented BMRs aligned with:
o Morocco DMP requirements
o EU GMP (EudraLex Volume 4)
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 Morocco DMP / EU GMP elements
o DMP vs US FDA / EU 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 Morocco DMP, 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 Morocco DMP / EU GMP vs US FDA / WHO 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 & automation
o Morocco, EU, and global export requirements

Our Global Experience (Supporting Morocco from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience supporting Morocco-to-EU / US / WHO supply chains
• Strong exposure to:
o APIs & intermediates
o Oral solid dosage forms
o Injectables & sterile products
o Biopharma-support & high-compliance facilities
• Regular interaction with:
o Morocco DMP
o EU Competent Authorities
o US FDA
o WHO / PIC/S regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• Morocco DMP GMP requirements
• EU GMP (EudraLex Volume 4)
• 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 Morocco

• 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 Moroccan Manufacturers Choose BMRx

• 🇲🇦 Strong alignment with Morocco DMP & EU GMP expectations
• 🌍 Export-oriented BMRs accepted globally
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced DMP / 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 Moroccan manufacturers for African, EU & global regulatory success