BMRx – Batch Manufacturing Record (BMR) Services in Ankleshwar

India-Compliant | Export-Oriented | 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 manufacturers in Ankleshwar GIDC supplying to Indian and international regulated markets.

Since 2008, BMRx has supported pharmaceutical, API, chemical, cosmetic, herbal, food, and specialty chemical manufacturers across Gujarat and India with regulatory-compliant, authority-acceptable BMR documentation, ensuring smooth approvals, inspection readiness, and reduced regulatory observations.

Who We Serve in Ankleshwar

We work closely with Ankleshwar-based companies involved in:

• API & intermediate manufacturing
• Bulk drugs & specialty chemicals
• Export-oriented manufacturing units
• Contract manufacturing (CMOs & CDMOs)
• New plant commissioning & site approvals
• Technology transfer & scale-up
• Regulatory inspections and GMP audits

Our BMR Services for Ankleshwar Manufacturers

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

✅ BMR Preparation

• Preparation of process-specific, product-wise BMRs aligned with:
o Indian GMP (Schedule M)
o US FDA (21 CFR Parts 210 & 211)
o EU GMP
o WHO GMP
o PIC/S GMP
• Non-generic, shop-floor-driven BMRs for APIs, intermediates, and formulations
• Operator-friendly formats suitable for large-scale and continuous operations
• Strong focus on critical process parameters, IPCs, yields, and reconciliation

✅ BMR Review & GMP Compliance Check

• Independent technical, GMP, and data integrity review of existing BMRs
• Identification of:
o Missing GMP elements
o Inadequate controls or IPC documentation
o Data integrity and traceability gaps
o US FDA / EU inspection-critical deficiencies
• Alignment with current regulatory expectations

✅ Regulatory Query & Inspection Support

• Support during CDSCO / State FDA / US FDA / EU inspections
• Handling of BMR-related observations and queries:
o Post-inspection
o During audits
o For warning letter / deficiency remediation
• CAPA-linked BMR corrections and upgrades

✅ Gap Assessment & Remediation

• Detailed gap analysis of existing BMRs against:
o Updated Schedule M & global GMP guidelines
o Export market expectations
• Practical, floor-executable corrective actions
• Risk-based remediation for APIs and high-risk processes

✅ Customized BMR Templates

• Regulator-accepted, ready-to-use BMR templates
• Custom-built based on:
o Reaction chemistry & process flow
o Equipment trains & utilities
o Batch size and scale
o Hazardous & critical operations
o Export and customer audit requirements

Our Experience in Gujarat & Ankleshwar Belt

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Strong exposure to Ankleshwar, Bharuch, Panoli, Jhagadia, Dahej, Vapi clusters
• Extensive experience with:
o APIs & intermediates
o Bulk drugs
o Specialty & fine chemicals
o Agrochemicals
o Solvents & industrial chemicals
• Regular interaction with:
o Gujarat FDCA
o CDSCO
o US FDA
o EU authorities
o WHO / PIC/S inspectors

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• Indian GMP (Schedule M)
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10
• Customer- and country-specific export requirements

Industries We Support in Ankleshwar

• APIs & Intermediates
• Bulk Drugs
• Specialty & Fine Chemicals
• Agrochemicals
• Cosmetics & Personal Care Ingredients
• Herbal & Natural Extracts
• Food & Nutraceutical Ingredients
• Industrial Chemicals

Why Ankleshwar Manufacturers Choose BMRx

• 🏭 Deep understanding of Ankleshwar manufacturing realities
• 🌍 Export-oriented BMRs accepted by global regulators
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced US FDA / EU GMP observations
• 🧠 Strong API, chemical & GMP expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional, and deadline-driven
• 👷 Operator-friendly formats for complex operations

How We Start the Project

To initiate BMR preparation or review, we typically require:

• Product and process details
• Reaction scheme / process flow diagram
• Equipment list & batch size
• Target export markets and 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 Ankleshwar manufacturers for India & global regulatory success