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

Nicaragua-Compliant | 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 Nicaragua pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers supplying to domestic and international regulated markets.

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

Who We Serve in Nicaragua

We work with Nicaragua-based companies involved in:

• Manufacturing for the Nicaraguan domestic market (Ministry of Health – MINSA)
• Export to US, EU, UK, Central America, Caribbean, Africa & LATAM
• Contract manufacturing (CMOs & CDMOs)
• Technology transfer and scale-up projects
• New manufacturing site approvals
• Regulatory inspections and GMP audits

Our BMR Services for Nicaraguan Manufacturers

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

✅ BMR Preparation

• Preparation of country-specific and export-oriented BMRs aligned with:
o MINSA (Nicaragua) requirements
o US FDA (21 CFR Parts 210 & 211)
o EU GMP
o WHO GMP
o PIC/S GMP
• Product-specific, process-driven, non-generic BMRs
• Operator-friendly, shop-floor-ready formats
• Strong focus on traceability, reconciliation, and data integrity

✅ BMR Review & GMP Compliance Check

• Independent technical and GMP review of existing BMRs
• Identification of:
o Missing GMP elements
o Documentation and execution gaps
o Data integrity risks
o Inspection-critical weaknesses
• Alignment with current international regulatory expectations

✅ Regulatory Query & Inspection Support

• Handling of MINSA / FDA / Authority queries related to BMRs:
o Post-submission
o Post-inspection
o During GMP audits
• Support for CAPA-linked BMR corrections
• Inspection response-ready documentation

✅ Gap Assessment & Remediation

• Gap analysis of existing BMRs against:
o Updated WHO / PIC/S / FDA / EU GMP guidelines
o Export-market regulatory expectations
• Practical, floor-ready corrective actions
• Risk-based remediation strategies

✅ Customized BMR Templates

• Regulator-accepted, ready-to-use BMR templates
• Customization based on:
o Dosage form
o Equipment & batch size
o Manufacturing process
o Facility layout & utilities
o Domestic and export market requirements

Our Global Experience (Supporting Nicaragua from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive exposure across:
o Central America & LATAM
o Africa
o Asia
o Middle East
o Europe
• Experience with:
o APIs & intermediates
o Finished dosage forms
o Cosmetics & personal care
o Herbal & traditional medicines
o Food & nutraceutical ingredients
o Chemicals & agrochemicals
• Strong interaction with:
o National health authorities
o US FDA
o EU authorities
o WHO
o PIC/S regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)
• MINSA (Nicaragua) & country-specific MOH expectations
• Import-country regulatory requirements for exports

Industries We Support in Nicaragua

• Pharmaceuticals & APIs
• Cosmetics & Personal Care
• Herbal & Natural Products
• Food & Nutraceutical Ingredients
• Essential Oils & Extracts
• Agrochemicals
• Industrial Chemicals

Why Nicaraguan Manufacturers Choose BMRx

• 🌍 Export-oriented BMRs accepted globally
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced regulatory observations
• 🧠 Technical + GMP + regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional, and deadline-driven
• 👷 Operator-friendly formats for shop-floor execution
• 🤝 Strong understanding of Central American manufacturing realities

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 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 Nicaraguan manufacturers for global regulatory success.