BMRx – Batch Manufacturing Record (BMR) Services in Vadodara

Gujarat State FDA | CDSCO | US FDA | EU GMP | WHO | PIC/S Compliant
Pharma, API & Chemical Hub Focused | Inspection-Ready | Export-Oriented

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, chemical, and life-science manufacturers in Vadodara and Central Gujarat supplying to Indian and international regulated markets.

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

Who We Serve in Vadodara & Central Gujarat

We work closely with companies involved in:

• Pharmaceutical formulation manufacturing
• APIs, intermediates & bulk drugs
• Chemical & specialty chemical manufacturing
• Pharmaceutical CMOs & CDMOs
• Manufacturing for Indian market (CDSCO & Gujarat State FDA)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Technology transfer, scale-up & site expansion projects
• Companies preparing for US FDA, EU GMP, WHO, CDSCO inspections

Our BMR Services for Vadodara Manufacturers

✅ BMR Preparation

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

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

Key Features
• Equipment-wise and batch-size-specific BMRs
• Strong control of CPPs, IPCs & yield reconciliation
• Data-integrity-focused, audit-defensible documentation
• Operator-friendly shop-floor execution formats

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing GMP or ICH Q7 elements
• Inadequate CPP, IPC, or yield documentation
• Data integrity & traceability gaps (ALCOA+)
• Inspection-critical weaknesses highlighted during audits

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

✅ Regulatory Query & Inspection Support

Support for BMR-related queries during:

• Gujarat 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
– ICH Q7 requirements
– US FDA & EU GMP expectations
• Practical, plant-ready corrective actions
• Alignment with validation, cleaning & quality systems

✅ Customized BMR Templates

• Ready-to-use, regulator-accepted BMR templates
• Customized based on:
– Equipment & reactor type
– Batch size & scale
– Manufacturing process
– Facility layout & utilities
– Domestic & export regulatory pathways

Our Experience in Vadodara Pharma & Chemical Cluster

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience with Vadodara, Savli, Nandesari, Padra, Halol, Ankleshwar corridors
• Strong exposure to API, formulation & chemical export-oriented facilities

Product Categories Covered
• APIs & intermediates
• Finished dosage forms
• Specialty & industrial chemicals
• Agrochemical actives
• Nutraceutical & herbal products

Regulatory Standards Followed

All BMR documentation is prepared in line with:

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

Industries We Support in Vadodara

• Pharmaceutical formulations
• APIs & bulk drugs
• Chemical & specialty chemical manufacturing
• Contract manufacturing units (CMOs/CDMOs)
• Nutraceutical & herbal manufacturers

Why Vadodara Manufacturers Choose BMRx

• 🏭 Strong understanding of Vadodara & Gujarat manufacturing ecosystem
• 🌍 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 / API details
• Manufacturing process & flow diagrams
• Equipment & reactor list
• Batch size & scale
• Target export markets
• 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 Vadodara manufacturers for India and global regulatory success.