BMRx – Global Batch Manufacturing Record (BMR) Services for Sri Lanka

NMRA–Aligned | WHO 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 in Sri Lanka supplying to domestic and international regulated markets.

Since 2008, BMRx has supported manufacturers across South Asia and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the National Medicines Regulatory Authority (NMRA) Sri Lanka, WHO GMP, and global inspection readiness.

Who We Serve in Sri Lanka

We work with Sri Lanka–based organizations involved in:

• Manufacturing for the Sri Lanka domestic market (NMRA)
• Export to South Asia, ASEAN, GCC, Africa & other regulated markets
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer & scale-up projects
• New manufacturing site approvals & NMRA licensing
• NMRA inspections, WHO audits & customer audits

Our BMR Services for Sri Lanka Manufacturers

✅ BMR Preparation

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

• NMRA Sri Lanka 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
• Clear in-process controls, yields & critical parameters
• Inspection-ready documentation acceptable to NMRA & global authorities

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

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

Deliverables include clear, implementable remediation recommendations.

✅ Regulatory Query & Inspection Support

Support during:

• NMRA post-submission queries
• NMRA GMP inspections & follow-ups
• WHO audits & customer inspections
• Export-market regulatory reviews

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

✅ Gap Assessment & Remediation

Comprehensive gap analysis of existing BMRs against:

• NMRA Sri Lanka GMP requirements
• WHO GMP expectations
• PIC/S & export-market MOH requirements

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

✅ Customized BMR Templates

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

• Dosage form
• Equipment & batch size
• Manufacturing process
• Facility layout & utilities
• Target domestic & export markets

Our Global Experience (Supporting Sri Lanka from India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Sri Lanka
– South Asia
– ASEAN
– Middle East
– Africa
– Europe
– LATAM

Product Categories Supported:
• Finished dosage forms
• APIs & intermediates
• Cosmetics & personal care
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
• Chemicals & agrochemicals

Regulatory Interaction Experience With:
• NMRA Sri Lanka
• WHO
• US FDA
• EU Authorities
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• NMRA Sri Lanka 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 Sri Lanka

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

Why Sri Lanka Manufacturers Choose BMRx

• 🇱🇰 Strong understanding of NMRA & WHO GMP expectations
• 🌍 Export-oriented BMRs accepted globally
• 📋 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 initiate BMR preparation or review, we typically require:

• Product & formulation details
• Manufacturing 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 Sri Lankan manufacturers for regional and global regulatory success.