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

Guyana MOH–Aligned | WHO & US FDA 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 supplying to the Guyana market and exporting across CARICOM, Latin America, North America, and global regulated markets.

Since 2008, BMRx has supported manufacturers across the Caribbean, LATAM, and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Ministry of Health, Guyana, Government Analyst–Food and Drug Department (GA-FDD), WHO GMP, and global inspection readiness.

Who We Serve in Guyana

We work with Guyana-based and Guyana-focused organizations involved in:

• Manufacturing for the Guyana domestic market (MOH / GA-FDD)
• Export to CARICOM & international markets
• Importers, local packers & secondary manufacturers
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer & scale-up projects
• MOH / GA-FDD inspections, WHO audits & customer inspections

Our BMR Services for Guyana Market Products

✅ BMR Preparation

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

• Guyana MOH / GA-FDD GMP requirements
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• PIC/S GMP Requirements

Key Features
• Non-generic, facility-specific BMRs
• Operator-friendly & shop-floor executable formats
• Clearly defined IPCs, CPPs, CQAs & yields
• Inspection-ready documentation acceptable to GA-FDD, WHO & global authorities

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing GA-FDD / WHO GMP elements
• Documentation & data-integrity gaps
• Inspection-critical weaknesses
• Non-alignment with CARICOM & export-market expectations

Deliverables include clear, implementable remediation recommendations.

✅ Regulatory Query & Inspection Support

Support during:

• Guyana MOH / GA-FDD post-submission queries
• GA-FDD GMP inspections & follow-ups
• WHO audits & partner 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:

• Guyana MOH / GA-FDD GMP requirements
• WHO & US FDA GMP expectations
• PIC/S & export-market MOH requirements

With practical, floor-ready corrective actions suitable for Guyana-based 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 Guyana, CARICOM & export markets

Our Global Experience (Supporting Guyana from India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Guyana
– Caribbean & CARICOM
– Latin America
– United States
– Europe
– Asia

Product Categories Supported
• Pharmaceutical finished dosage forms
• APIs & intermediates
• Sterile & injectable products
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
• Cosmetics & personal care

Regulatory Interaction Experience With
• Ministry of Health – Guyana / GA-FDD
• WHO
• US FDA
• EU Authorities
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• Guyana MOH / GA-FDD GMP Guidelines
• WHO GMP
• US FDA cGMP (21 CFR 210 & 211)
• EU GMP
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)

Industries We Support in Guyana

• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Sterile & Injectable Manufacturing
• Herbal & Traditional Products
• Nutraceuticals & Food Ingredients
• Cosmetics & Personal Care

Why Guyana Market Companies Choose BMRx

• 🇬🇾 Strong understanding of Guyana MOH, GA-FDD & WHO GMP expectations
• 🌍 Export-oriented BMRs accepted across CARICOM & global markets
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced regulatory & donor inspection observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven delivery
• 👷 Operator-friendly formats for reliable 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 Guyanese manufacturers for CARICOM, LATAM & global regulatory success