BMRx – Batch Manufacturing Record (BMR) Services in Kolkata

West Bengal State FDA | CDSCO | US FDA | EU GMP | WHO | PIC/S Compliant
Legacy & Export Manufacturing Focused | Inspection-Ready | Globally Aligned

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Batch Manufacturing Record (BMR) Preparation, Review, and Remediation Services for pharmaceutical, API, and allied manufacturers in Kolkata and West Bengal supplying to Indian and international regulated markets.

Since 2008, BMRx has supported Kolkata-based formulation units, API manufacturers, chemical plants, and export-oriented companies with regulatory-compliant, authority-acceptable BMR documentation, enabling smooth approvals, inspection readiness, and reduced regulatory observations.

Who We Serve in Kolkata & West Bengal

We work closely with companies involved in:

• Pharmaceutical formulation manufacturing
• APIs, intermediates & bulk drugs
• Legacy manufacturing plants undergoing upgrades
• Pharmaceutical CMOs & CDMOs
• Manufacturing for Indian market (CDSCO & West Bengal State FDA)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Technology transfer, plant modernization & scale-up projects
• Companies preparing for US FDA, EU GMP, WHO, CDSCO inspections

Our BMR Services for Kolkata Manufacturers

✅ BMR Preparation

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

• Indian GMP (Schedule M)
• West Bengal State FDA expectations
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• WHO GMP
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)

Key Features
• Dosage-form-specific BMRs (OSD, liquids, injectables, etc.)
• Formats suitable for legacy plants and phased upgrades
• Strong control of CPPs, IPCs & reconciliation
• Data-integrity-focused, audit-defensible documentation
• Operator-friendly shop-floor execution

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing GMP or documentation elements
• Data integrity, traceability & ALCOA+ gaps
• Inadequate in-process controls or recording practices
• Inspection-critical weaknesses observed in audits

Outcome: Corrected, strengthened BMRs aligned with current Indian and global GMP expectations.

✅ Regulatory Query & Inspection Support

Support for BMR-related queries during:

• West Bengal State FDA & CDSCO inspections
• US FDA audits
• EU GMP & WHO inspections
• Pre-approval & post-approval inspections
• Post-inspection CAPA implementation

Includes BMR corrections, justifications, and regulator-acceptable responses.

✅ Gap Assessment & Remediation

• Gap analysis of existing BMRs against:
– Updated Schedule M
– US FDA & EU GMP expectations
– WHO & PIC/S requirements
• Practical, shop-floor-ready corrective actions
• Alignment with validation and quality systems

✅ Customized BMR Templates

• 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 Experience in Kolkata Pharma Ecosystem

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience with Kolkata, Howrah, Hooghly, Kalyani, Haldia industrial zones
• Strong exposure to legacy facilities transitioning to global GMP

Product Categories Covered
• Finished dosage forms
• APIs & intermediates
• Nutraceutical & herbal products
• Cosmetics & personal care
• Chemicals & specialty products

Regulatory Standards Followed

All BMR documentation is prepared in line with:

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

Industries We Support in Kolkata

• Pharmaceutical formulations
• APIs & intermediates
• Contract manufacturing (CMOs/CDMOs)
• Nutraceutical & herbal manufacturers
• Cosmetics & personal care
• Export-oriented manufacturing units

Why Kolkata Manufacturers Choose BMRx

• 🏭 Strong understanding of legacy & modern manufacturing environments
• 🌍 Export-oriented, globally acceptable BMRs
• 📋 Inspection-ready, audit-defensible documentation
• 🔍 Reduced regulatory & data-integrity observations
• 🧠 Deep technical, GMP & regulatory expertise
• 🛠️ Process-specific, non-generic BMRs
• 🔒 Confidential, professional & deadline-driven execution
• 👷 Operator-friendly records for real shop-floor use

How We Start the Project

To initiate BMR preparation or review, we typically request:

• Product and formulation details
• Manufacturing process & flow diagrams
• Equipment list and batch size
• Target markets and regulatory strategy
• 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 Kolkata manufacturers for India and global regulatory success