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

Maldives-Compliant | WHO-Aligned | Import & Export-Ready Documentation

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Batch Manufacturing Record (BMR) Preparation & Review Services for Maldivian pharmaceutical, herbal, nutraceutical, cosmetic, food, and chemical manufacturers supplying to domestic, island-based distribution, and international markets.

Since 2008, BMRx has supported manufacturers across South Asia, Southeast Asia, the Middle East, Africa, Europe, and LATAM with regulatory-compliant, authority-acceptable BMR documentation, supporting product registration, import approvals, audits, and export readiness.

Who We Serve in Maldives

We work with Maldives-based organizations involved in:

• Manufacturing for the Maldives domestic market (MFDA – Maldives Food and Drug Authority)
• Local pharmaceutical formulation & repackaging units
• Herbal, traditional medicine & nutraceutical manufacturers
• Food, dietary supplement & cosmetic producers
• Government, hospital & island-level supply programs
• Export to South Asia, ASEAN, Middle East & NGO-supported markets

Our BMR Services for Maldivian Manufacturers

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

✅ BMR Preparation

• Preparation of Maldives-compliant and export-oriented BMRs aligned with:
o MFDA requirements
o WHO GMP Guidelines
o PIC/S GMP (where applicable)
o US FDA / EU GMP (for export-oriented facilities)
• Product-specific, process-driven, non-generic BMRs
• Clear documentation of raw materials, processing steps, IPCs, yields, and reconciliation
• Simple, operator-friendly, audit-ready formats

✅ BMR Review & GMP Compliance Check

• Independent technical and GMP review of existing BMRs
• Identification of:
o Missing GMP elements
o Documentation gaps impacting MFDA approval or audits
o Data-integrity and traceability risks
• Alignment with WHO and importing-country expectations

✅ Regulatory Query & Inspection Support

• Support for MFDA, WHO, and importing-country authority queries
• Assistance during:
o Product registration
o GMP audits & inspections
o Import / export approvals
• CAPA-linked BMR corrections and upgrades

✅ Gap Assessment & Remediation

• Gap analysis of existing BMRs against:
o WHO GMP standards
o Import- and export-market documentation requirements
• Practical, floor-ready corrective actions suitable for small-scale and island-based facilities

✅ Customized BMR Templates

• Ready-to-use, regulator-accepted BMR templates
• Customized based on:
o Product type (pharma, herbal, food, cosmetic)
o Batch size & equipment availability
o Facility layout & utilities
o Domestic supply and export objectives

Our Global Experience (Supporting Maldives from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Strong experience with small-market & island-nation GMP environments
• Extensive work across:
o South Asia
o Southeast Asia
o Middle East
o Africa
• Exposure to:
o Essential medicines
o Herbal & nutraceutical products
o Food and cosmetic manufacturing
• Regular interaction with:
o WHO
o National Food & Drug Authorities
o Importing-country regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• MFDA requirements (Maldives)
• WHO GMP Guidelines
• PIC/S GMP (where applicable)
• US FDA cGMP (for exports, where required)
• EU GMP (for exports, where required)
• ICH Q7 / Q9 (where applicable)

Industries We Support in Maldives

• Pharmaceuticals & Essential Medicines
• Herbal & Traditional Medicine Products
• Nutraceuticals & Food Supplements
• Food Processing & Ingredients
• Cosmetics & Personal Care
• Natural Extracts & Essential Oils
• Chemicals & Industrial Products (limited-scope GMP)

Why Maldivian Manufacturers Choose BMRx

• 🌍 Strong WHO-aligned documentation expertise
• 📋 MFDA-ready and authority-acceptable BMRs
• 🔍 Reduced registration & inspection observations
• 🧠 Deep understanding of small-scale & island GMP realities
• 🛠️ Practical, non-generic, process-specific BMRs
• 🔒 Confidential, professional, and deadline-driven
• 👷 Simple, operator-friendly formats

How We Start the Project

To initiate BMR preparation or review, we typically require:

• Product details and formulation
• Manufacturing process & flow diagram
• Equipment list and batch size
• Target markets (domestic / export / hospital / NGO supply)
• 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 Maldivian manufacturers for domestic, import & global regulatory success