BMRx – Global Batch Manufacturing Record (BMR) Services for South Africa

South Africa–Compliant | PIC/S & 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 South African pharmaceutical, API, biotech, cosmetic, herbal, food, and chemical manufacturers supplying to domestic, SADC, African, 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 South Africa

We work with South Africa–based companies involved in:

• Manufacturing for the South African domestic market
(SAHPRA – South African Health Products Regulatory Authority)
• Export to SADC, US, EU, UK, GCC, Africa & LATAM
• API & intermediate manufacturing
• Finished dosage forms (OSD, injectables, sterile products, biologics-support)
• Contract manufacturing (CMOs & CDMOs)
• Technology transfer & global scale-up projects
• SAHPRA, US FDA, EU GMP & WHO inspections

Our BMR Services for South African Manufacturers

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

✅ BMR Preparation

• Preparation of South Africa–compliant and export-oriented BMRs aligned with:
o SAHPRA GMP requirements
o PIC/S GMP
o US FDA (21 CFR Parts 210 & 211)
o EU GMP (EudraLex Volume 4)
o WHO GMP
• Product-specific, process-driven, non-generic BMRs
• Clear documentation of CPPs, IPCs, CQAs, 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 SAHPRA / PIC/S GMP elements
o SAHPRA vs US FDA / EU GMP gaps
o Data-integrity and traceability risks
o Inspection-critical weaknesses
• Alignment with current global regulatory expectations

✅ Regulatory Query & Inspection Support

• Support during SAHPRA, 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 SAHPRA / PIC/S GMP vs US FDA / EU GMP
o Export-market documentation expectations
• Practical, shop-floor-executable corrective actions
• Risk-based remediation for sterile, biotech, and high-risk 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 South Africa domestic and global export requirements

Our Global Experience (Supporting South Africa from India)

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

Regulatory Standards Followed

All BMR documentation is prepared in line with:

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

Industries We Support in South Africa

• 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 South African Manufacturers Choose BMRx

• 🇿🇦 Strong alignment with SAHPRA & PIC/S GMP expectations
• 🌍 Export-oriented BMRs accepted globally
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced SAHPRA / US FDA / EU 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 South African manufacturers for domestic, African & global regulatory success