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

DGDA-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 pharmaceutical and regulated-industry manufacturers in Bangladesh supplying to domestic and international markets.

Since 2008, BMRx has supported manufacturers across South Asia with regulatory-compliant, authority-acceptable BMR documentation, ensuring DGDA approvals, inspection readiness, and reduced regulatory observations during audits by global health authorities.

Who We Serve in Bangladesh

We work closely with Bangladesh-based companies involved in:

• Manufacturing for Bangladesh domestic market (DGDA)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Contract Manufacturing Organizations (CMOs & CDMOs)
• Technology transfer & scale-up projects
• New manufacturing site approvals & expansions
• DGDA, WHO, US FDA, EU GMP inspections & audits

Our BMR Services for Bangladesh Manufacturers

✅ BMR Preparation

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

• DGDA (Bangladesh) GMP requirements
• US FDA (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• WHO GMP
• PIC/S GMP

Key Features:
• Non-generic, facility-specific BMRs
• Operator-friendly & shop-floor executable formats
• Inspection-ready documentation accepted globally
• Clear in-process controls, yields, and critical steps

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing DGDA / GMP elements
• Data integrity & documentation gaps
• Inspection-critical weaknesses
• Non-alignment with export market expectations

Deliverables include clear correction recommendations aligned with current regulatory trends.

✅ Regulatory Query & Inspection Support

We support Bangladesh manufacturers during:

• DGDA post-submission queries
• WHO Prequalification (PQ) audits
• US FDA / EU GMP inspections
• Third-party & customer audits

Including:
• Authority query responses
• Inspection observation remediation
• CAPA-linked BMR corrections

✅ Gap Assessment & Remediation

Comprehensive gap analysis of existing BMRs against:

• DGDA GMP requirements
• WHO / PIC/S expectations
• Export country MOH requirements

With practical, floor-ready corrective actions suitable for Bangladesh manufacturing environments.

✅ Customized BMR Templates

Provision of ready-to-use, regulator-accepted BMR templates, customized based on:

• Dosage form (tablets, capsules, injectables, liquids, etc.)
• Equipment & batch size
• Manufacturing process
• Facility layout & utilities
• Target export markets

Our Global Experience (Supporting Bangladesh from India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Bangladesh
– India
– Asia
– Middle East
– Africa
– Europe
– LATAM

Product Categories Supported:
• APIs & Intermediates
• Finished Dosage Forms
• Cosmetics & Personal Care
• Herbal & Traditional Medicines
• Food & Nutraceutical Ingredients
• Chemicals & Agrochemicals

Regulatory Interaction Experience With:
• DGDA – Bangladesh
• US FDA
• EU Authorities
• WHO
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• DGDA Bangladesh GMP Guidelines
• WHO GMP
• US FDA cGMP (21 CFR 210 & 211)
• EU GMP Guidelines
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)
• Country-specific MOH expectations for exports

Industries We Support in Bangladesh

• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Cosmetics & Personal Care Products
• Herbal & Traditional Medicines
• Nutraceuticals & Food Ingredients
• Agrochemicals
• Industrial Chemicals

Why Bangladesh Manufacturers Choose BMRx

• 🇧🇩 Strong understanding of Bangladesh DGDA & WHO GMP expectations
• 🌍 Export-oriented BMRs accepted by global regulators
• 📋 Inspection-ready & auditable documentation
• 🔍 Reduced inspection observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven delivery
• 👷 Operator-friendly formats for shop-floor execution

How We Initiate a BMR Project

To start BMR preparation or review, we typically request:

• Product & formulation details
• Manufacturing process & flow diagram
• Equipment list & batch size
• Target export 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 Bangladesh manufacturers for global regulatory success.